Trial Outcomes & Findings for Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors (NCT NCT01075399)
NCT ID: NCT01075399
Last Updated: 2013-08-30
Results Overview
Primary tumor uptake of \[F 18\]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.
COMPLETED
PHASE2
50 participants
Time between 1st and 2nd scan was 1 to 6 days
2013-08-30
Participant Flow
A total of 50 patients were enrolled into the study. There were 42 of 50 patients received at least one dose of \[F-18\]HX4 and had safety data collected. There were 39 of 50 patients completed two pre-treatment \[F-18\]HX4 PET/CT scans and were included in analyses to assess reproducibility.
Participant milestones
| Measure |
[F 18]HX4
\[F 18\]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with \[F 18\]HX4
|
|---|---|
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Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors
Baseline characteristics by cohort
| Measure |
[F 18]HX4
n=42 Participants
\[F 18\]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with \[F 18\]HX4
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age Continuous
|
59.0 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time between 1st and 2nd scan was 1 to 6 daysPopulation: Based upon inclusion/exclusion criteria
Primary tumor uptake of \[F 18\]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.
Outcome measures
| Measure |
Subjects That Received 1st and 2nd [F18] HX4 Scans
n=39 Participants
Single arm study. This group includes all subjects that successfully received \[F18\]HX4 PET scan on 2 separate occasions within 6 days apart to assess reproducibility in measuring tumor hypoxia.
|
|---|---|
|
Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors
|
39 participants
|
Adverse Events
[F 18]HX4
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Edward M. Aten, MD, President
Certus International, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place