Trial Outcomes & Findings for Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer (NCT NCT01877187)
NCT ID: NCT01877187
Last Updated: 2020-04-15
Results Overview
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): \>= 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
30 days, 90 days, and 180 days
Results posted on
2020-04-15
Participant Flow
Participant milestones
| Measure |
Lipiodol
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
Completed 30 Day f/u
|
35
|
|
Overall Study
Completed 90 Day f/u
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Lipiodol
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Declining clinical status
|
11
|
|
Overall Study
Liver transplant
|
2
|
Baseline Characteristics
Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Baseline characteristics by cohort
| Measure |
Lipiodol
n=39 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
|---|---|
|
Age, Continuous
|
61.28 years
STANDARD_DEVIATION 10.75 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
|
Tumor Type
Hepatocellular carcinoma
|
22 Participants
n=93 Participants
|
|
Tumor Type
Neuroendocrine: GI
|
4 Participants
n=93 Participants
|
|
Tumor Type
Neuroendocrine: pancreatic
|
2 Participants
n=93 Participants
|
|
Tumor Type
Neuroendocrine: bronchial
|
1 Participants
n=93 Participants
|
|
Tumor Type
Cholangiocarcinoma
|
8 Participants
n=93 Participants
|
|
Tumor Type
Cutaneous melanoma
|
1 Participants
n=93 Participants
|
|
Tumor Type
Uveal melanoma
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30 days, 90 days, and 180 daysPopulation: 18 HCC and 16 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): \>= 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Lipiodol (HCC)
n=18 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
30 day f/u · Responders
|
1 Participants
|
1 Participants
|
—
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
30 day f/u · Non-responders
|
17 Participants
|
15 Participants
|
—
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
90 day f/u · Responders
|
5 Participants
|
3 Participants
|
—
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
90 day f/u · Non-responders
|
6 Participants
|
4 Participants
|
—
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
180 day f/u · Responders
|
4 Participants
|
2 Participants
|
—
|
|
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
180 day f/u · Non-responders
|
7 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days, 90 days, 180 daysPopulation: 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by RECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by RECIST criteria. Nonresponders are all other subjects.
Outcome measures
| Measure |
Lipiodol (HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
n=30 Participants
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Baseline Enhancing Tumor and Response by RECIST Criteria
(30 day) Responders
|
95.1 % tumor enhancement
Interval 95.1 to 95.1
|
97.30 % tumor enhancement
Interval 97.3 to 97.3
|
96.2 % tumor enhancement
Interval 95.1 to 97.3
|
|
Baseline Enhancing Tumor and Response by RECIST Criteria
(30 day) Nonresponders
|
53.4 % tumor enhancement
Interval 6.1 to 99.8
|
50.7 % tumor enhancement
Interval 6.0 to 81.9
|
52.1 % tumor enhancement
Interval 6.0 to 99.8
|
|
Baseline Enhancing Tumor and Response by RECIST Criteria
(90 day) Responders
|
65.2 % tumor enhancement
Interval 29.6 to 99.8
|
89.6 % tumor enhancement
Interval 81.9 to 97.3
|
79.4 % tumor enhancement
Interval 29.6 to 99.8
|
|
Baseline Enhancing Tumor and Response by RECIST Criteria
(90 day) Nonresponders
|
50.6 % tumor enhancement
Interval 36.3 to 93.4
|
30.4 % tumor enhancement
Interval 6.0 to 67.8
|
42.4 % tumor enhancement
Interval 6.0 to 93.4
|
|
Baseline Enhancing Tumor and Response by RECIST Criteria
(180 day) Responders
|
77.0 % tumor enhancement
Interval 53.4 to 99.8
|
89.6 % tumor enhancement
Interval 81.9 to 97.3
|
81.9 % tumor enhancement
Interval 53.4 to 99.8
|
|
Baseline Enhancing Tumor and Response by RECIST Criteria
(180 day) Nonresponders
|
46.2 % tumor enhancement
Interval 29.6 to 93.4
|
43.1 % tumor enhancement
Interval 18.4 to 67.8
|
46.2 % tumor enhancement
Interval 18.4 to 93.4
|
SECONDARY outcome
Timeframe: 30 days, 90 days, and 180 daysPopulation: 18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with mRECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per modified Response Evaluation Criteria in Solid Tumors (mRECIST): Complete Response (CR): Disappearance of all intratumoral arterial enhancement in target lesions Partial Response (PR): At least 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Lipiodol (HCC)
n=18 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
30 day f/u · Responders
|
9 Participants
|
2 Participants
|
—
|
|
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
30 day f/u · Non-responders
|
9 Participants
|
12 Participants
|
—
|
|
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
90 day f/u · Responders
|
6 Participants
|
3 Participants
|
—
|
|
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
90 day f/u · Non-responders
|
5 Participants
|
4 Participants
|
—
|
|
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
180 day f/u · Responders
|
6 Participants
|
2 Participants
|
—
|
|
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
180 day f/u · Non-responders
|
5 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 daysPopulation: 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by mRECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by mRECIST criteria. Nonresponders are all other subjects.
Outcome measures
| Measure |
Lipiodol (HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
n=30 Participants
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Baseline Enhancing Tumor and Response by mRECIST Criteria
(180 days) Nonresponders
|
50.6 % tumor enhancement
Interval 36.3 to 93.4
|
82.5 % tumor enhancement
Interval 67.8 to 97.3
|
53.4 % tumor enhancement
Interval 36.3 to 97.3
|
|
Baseline Enhancing Tumor and Response by mRECIST Criteria
(30 day) Responders
|
95.1 % tumor enhancement
Interval 6.1 to 99.8
|
53.7 % tumor enhancement
Interval 29.2 to 78.2
|
78.2 % tumor enhancement
Interval 6.1 to 99.8
|
|
Baseline Enhancing Tumor and Response by mRECIST Criteria
(30 days) Nonresponders
|
50.6 % tumor enhancement
Interval 9.6 to 93.4
|
52.7 % tumor enhancement
Interval 6.0 to 97.3
|
50.7 % tumor enhancement
Interval 6.0 to 97.3
|
|
Baseline Enhancing Tumor and Response by mRECIST Criteria
(90 days) Responders
|
74.1 % tumor enhancement
Interval 53.4 to 99.8
|
89.6 % tumor enhancement
Interval 81.9 to 97.3
|
79.4 % tumor enhancement
Interval 53.4 to 99.8
|
|
Baseline Enhancing Tumor and Response by mRECIST Criteria
(90 days) Nonresponders
|
41.8 % tumor enhancement
Interval 29.3 to 93.4
|
30.4 % tumor enhancement
Interval 6.0 to 67.8
|
41.8 % tumor enhancement
Interval 6.0 to 93.4
|
|
Baseline Enhancing Tumor and Response by mRECIST Criteria
(180 days) Responders
|
74.1 % tumor enhancement
Interval 29.6 to 99.8
|
50.1 % tumor enhancement
Interval 18.4 to 81.9
|
74.1 % tumor enhancement
Interval 18.4 to 99.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with WHO response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per WHO criteria: Complete Response (CR): disappearance of all lesions for \>= 4 weeks. Partial Response (PR): At least 50% decrease in sum of the products of diameters of target lesions. Overall Response: CR + PR.
Outcome measures
| Measure |
Lipiodol (HCC)
n=18 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Tumor Response by World Health Organization (WHO) Criteria
30 day f/u · Responders
|
2 Participants
|
1 Participants
|
—
|
|
Tumor Response by World Health Organization (WHO) Criteria
30 day f/u · Non-responders
|
16 Participants
|
15 Participants
|
—
|
|
Tumor Response by World Health Organization (WHO) Criteria
90 day f/u · Responders
|
4 Participants
|
3 Participants
|
—
|
|
Tumor Response by World Health Organization (WHO) Criteria
90 day f/u · Non-responders
|
7 Participants
|
4 Participants
|
—
|
|
Tumor Response by World Health Organization (WHO) Criteria
180 day f/u · Responders
|
4 Participants
|
2 Participants
|
—
|
|
Tumor Response by World Health Organization (WHO) Criteria
180 day f/u · Non-responders
|
7 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 daysPopulation: 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by WHO criteria. Responders are subjects that demonstrated Complete Response or Partial Response by WHO criteria. Nonresponders are all other subjects.
Outcome measures
| Measure |
Lipiodol (HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
n=30 Participants
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Baseline Enhancing Tumor and Response by WHO Criteria
(90 days) Nonresponders
|
46.2 % tumor enhancement
Interval 29.6 to 93.4
|
30.4 % tumor enhancement
Interval 6.0 to 67.8
|
42.1 % tumor enhancement
Interval 6.0 to 93.4
|
|
Baseline Enhancing Tumor and Response by WHO Criteria
(30 day) Responders
|
95.1 % tumor enhancement
Interval 95.1 to 9.51
|
97.3 % tumor enhancement
Interval 97.3 to 97.3
|
96.2 % tumor enhancement
Interval 95.1 to 97.3
|
|
Baseline Enhancing Tumor and Response by WHO Criteria
(30 days) Nonresponders
|
53.4 % tumor enhancement
Interval 6.1 to 99.8
|
50.7 % tumor enhancement
Interval 6.0 to 81.9
|
52.1 % tumor enhancement
Interval 6.0 to 99.8
|
|
Baseline Enhancing Tumor and Response by WHO Criteria
(90 days) Responders
|
77.0 % tumor enhancement
Interval 53.4 to 99.8
|
89.6 % tumor enhancement
Interval 81.9 to 97.3
|
81.9 % tumor enhancement
Interval 53.4 to 99.8
|
|
Baseline Enhancing Tumor and Response by WHO Criteria
(180 days) Responders
|
77.0 % tumor enhancement
Interval 53.4 to 99.8
|
97.3 % tumor enhancement
Interval 97.3 to 97.3
|
87.5 % tumor enhancement
Interval 53.4 to 99.8
|
|
Baseline Enhancing Tumor and Response by WHO Criteria
(180 days) Nonresponders
|
46.2 % tumor enhancement
Interval 29.6 to 93.4
|
67.8 % tumor enhancement
Interval 18.4 to 81.9
|
50.6 % tumor enhancement
Interval 18.4 to 93.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with EASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per EASL response: Complete Response (CR): complete disappearance of enhancing tissue in target lesions Partial Response (PR): At least 50% decrease in area of enhancing tissue in target lesions. Overall Response: CR+PR
Outcome measures
| Measure |
Lipiodol (HCC)
n=18 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
30 day f/u · Responders
|
11 Participants
|
2 Participants
|
—
|
|
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
30 day f/u · Non-responders
|
7 Participants
|
12 Participants
|
—
|
|
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
90 day f/u · Responders
|
7 Participants
|
5 Participants
|
—
|
|
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
90 day f/u · Non-responders
|
4 Participants
|
2 Participants
|
—
|
|
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
180 day f/u · Responders
|
7 Participants
|
4 Participants
|
—
|
|
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
180 day f/u · Non-responders
|
4 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 daysPopulation: 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by EASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by EASL criteria. Nonresponders are all other subjects.
Outcome measures
| Measure |
Lipiodol (HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
n=30 Participants
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Baseline Enhancing Tumor and Response by EASL Criteria
(30 days) Nonresponders
|
50.1 % tumor enhancement
Interval 9.6 to 93.4
|
46.6 % tumor enhancement
Interval 6.0 to 81.9
|
50.1 % tumor enhancement
Interval 6.0 to 93.4
|
|
Baseline Enhancing Tumor and Response by EASL Criteria
(30 day) Responders
|
77.0 % tumor enhancement
Interval 6.1 to 99.8
|
87.8 % tumor enhancement
Interval 78.2 to 97.3
|
78.2 % tumor enhancement
Interval 6.1 to 99.8
|
|
Baseline Enhancing Tumor and Response by EASL Criteria
(90 days) Responders
|
77.0 % tumor enhancement
Interval 53.4 to 99.8
|
62.1 % tumor enhancement
Interval 18.4 to 97.3
|
77.0 % tumor enhancement
Interval 18.4 to 99.8
|
|
Baseline Enhancing Tumor and Response by EASL Criteria
(90 days) Nonresponders
|
39.1 % tumor enhancement
Interval 29.6 to 50.6
|
36.9 % tumor enhancement
Interval 6.0 to 67.8
|
39.1 % tumor enhancement
Interval 6.0 to 67.8
|
|
Baseline Enhancing Tumor and Response by EASL Criteria
(180 days) Responders
|
71.2 % tumor enhancement
Interval 29.6 to 99.8
|
57.8 % tumor enhancement
Interval 18.4 to 97.3
|
71.2 % tumor enhancement
Interval 18.4 to 99.8
|
|
Baseline Enhancing Tumor and Response by EASL Criteria
(180 days) Nonresponders
|
47.6 % tumor enhancement
Interval 36.3 to 93.4
|
74.8 % tumor enhancement
Interval 67.8 to 81.9
|
60.6 % tumor enhancement
Interval 36.3 to 93.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 16 HCC and 14 non-HCC subjects had complete data for qEASL analysis at 30day f/u, 9 HCC and 7 non-HCC at 90 day f/u, and 9 HCC and 5 non-HCC at 180 day f/u.
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with qEASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per qEASL criteria: Complete Response (CR): Total disappearance of enhancing tumor volume in target lesions Partial Response (PR): At least 65% decrease in enhanced tumor volume after treatment. Overall Response: CR + PR
Outcome measures
| Measure |
Lipiodol (HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
180 day f/u · Non-responders
|
3 Participants
|
0 Participants
|
—
|
|
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
30 day f/u · Responders
|
6 Participants
|
1 Participants
|
—
|
|
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
30 day f/u · Non-responders
|
10 Participants
|
13 Participants
|
—
|
|
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
90 day f/u · Responders
|
5 Participants
|
4 Participants
|
—
|
|
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
90 day f/u · Non-responders
|
4 Participants
|
3 Participants
|
—
|
|
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
180 day f/u · Responders
|
6 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 days, 90 days, 180 daysPopulation: 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by qEASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by qEASL criteria. Nonresponders are all other subjects.
Outcome measures
| Measure |
Lipiodol (HCC)
n=16 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
n=14 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
n=30 Participants
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
Baseline Enhancing Tumor and Response by qEASL Criteria
(30 day) Responders
|
74.1 % tumor enhancement
Interval 50.6 to 97.6
|
81.9 % tumor enhancement
Interval 81.9 to 81.9
|
77.0 % tumor enhancement
Interval 50.6 to 97.6
|
|
Baseline Enhancing Tumor and Response by qEASL Criteria
(90 days) Responders
|
71.2 % tumor enhancement
Interval 50.6 to 99.8
|
81.9 % tumor enhancement
Interval 67.8 to 97.3
|
74.1 % tumor enhancement
Interval 50.6 to 99.8
|
|
Baseline Enhancing Tumor and Response by qEASL Criteria
(90 days) Nonresponders
|
39.1 % tumor enhancement
Interval 29.6 to 93.4
|
18.4 % tumor enhancement
Interval 6.0 to 42.4
|
36.3 % tumor enhancement
Interval 6.0 to 93.4
|
|
Baseline Enhancing Tumor and Response by qEASL Criteria
(180 days) Responders
|
62.3 % tumor enhancement
Interval 29.6 to 99.8
|
74.8 % tumor enhancement
Interval 18.4 to 97.3
|
69.5 % tumor enhancement
Interval 18.4 to 99.8
|
|
Baseline Enhancing Tumor and Response by qEASL Criteria
(180 days) Nonresponders
|
41.8 % tumor enhancement
Interval 36.3 to 93.4
|
—
|
41.8 % tumor enhancement
Interval 36.3 to 93.4
|
|
Baseline Enhancing Tumor and Response by qEASL Criteria
(30 days) Nonresponders
|
46.0 % tumor enhancement
Interval 6.1 to 99.8
|
50.7 % tumor enhancement
Interval 6.0 to 97.3
|
50.1 % tumor enhancement
Interval 6.0 to 99.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Kaplan-Meier survival analysis to estimate survival rate% at 6 months. Subjects are censored if survival is unknown at time point due to loss to followup.
Measure the association between baseline Lipiodol deposition and the 6-month survival rate by estimating median survival for each stratum, and by testing for homogeneity using a logrank test if hazards are proportional.
Outcome measures
| Measure |
Lipiodol (HCC)
n=39 Participants
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Lipiodol (Non-HCC)
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
|
Overall
Combined Lipiodol (HCC) and Lipiodol (Non-HCC)
|
|---|---|---|---|
|
6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE
|
67.6 percentage of partcipants
|
—
|
—
|
Adverse Events
Lipiodol/TACE
Serious events: 11 serious events
Other events: 33 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lipiodol/TACE
n=39 participants at risk
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
Adverse events assessed in relation to TACE procedure.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.1%
2/39 • Number of events 2 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Vascular disorders
Thromboembolic event
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Gastrointestinal disorders
Ascites
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Gastrointestinal disorders
Hepatic abscess
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Cardiac disorders
Pericardial effusion
|
2.6%
1/39 • Number of events 1 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
Other adverse events
| Measure |
Lipiodol/TACE
n=39 participants at risk
Lipiodol, 10cc per TACE.
Lipiodol: Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
Adverse events assessed in relation to TACE procedure.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
4/39 • Number of events 4 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
3/39 • Number of events 4 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Gastrointestinal disorders
Ascites
|
5.1%
2/39 • Number of events 4 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
General disorders
Edema limbs
|
5.1%
2/39 • Number of events 2 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
6/39 • Number of events 7 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
3/39 • Number of events 3 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Aspartate aminotransferase
|
23.1%
9/39 • Number of events 17 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
General disorders
Fatigue
|
17.9%
7/39 • Number of events 9 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
General disorders
Fever
|
5.1%
2/39 • Number of events 2 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Blood bilirubin increased
|
7.7%
3/39 • Number of events 6 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
3/39 • Number of events 4 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.1%
2/39 • Number of events 2 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.8%
5/39 • Number of events 5 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
3/39 • Number of events 3 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Lymphocyte count decreased
|
12.8%
5/39 • Number of events 6 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
6/39 • Number of events 6 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Platelet count decreased
|
7.7%
3/39 • Number of events 3 • 6 months post treatment
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place