Trial Outcomes & Findings for Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection (NCT NCT00918281)
NCT ID: NCT00918281
Last Updated: 2014-06-09
Results Overview
Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.
Results posted on
2014-06-09
Participant Flow
70 Subjects started and enrolled in this study. 41 Subjects completed this study and 29 did not complete this study.
Due to the number of subjects that did not complete this study, additional subjects were enrolled bring to total enrolment to 70 subjects.
Participant milestones
| Measure |
1 Fluciclatide Injection
AH111585 (18F) Injection : AH111585 (18F) Injection
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
1 Fluciclatide Injection
AH111585 (18F) Injection : AH111585 (18F) Injection
|
|---|---|
|
Overall Study
Physician Decision
|
29
|
Baseline Characteristics
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
Baseline characteristics by cohort
| Measure |
1 Fluciclatide Injection
n=49 Participants
Fluciclatide Injection (AH111585 (18F) Injection)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.Population: Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection).
Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.
Outcome measures
| Measure |
Imaging Session 1
n=39 Participants
Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi \[370 megabecquerels (MBq)\]
|
Imaging Session 2
n=39 Participants
Fluciclatide Injection (AH111585 (18F) Injection)
|
Relative Difference
n=39 Participants
The Relative difference between imaging sessions 1 and 2.
|
|---|---|---|---|
|
Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.
40 Minute Post Injection
|
4.536 Standardized Uptake Value
Standard Deviation 2.2113
|
4.671 Standardized Uptake Value
Standard Deviation 2.4485
|
0.0198 Standardized Uptake Value
Standard Deviation 0.16099
|
|
Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.
65 Minute Post Injection
|
4.584 Standardized Uptake Value
Standard Deviation 2.3266
|
4.675 Standardized Uptake Value
Standard Deviation 2.4489
|
0.0216 Standardized Uptake Value
Standard Deviation 0.17466
|
|
Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.
90 Minute Post Injection
|
4.404 Standardized Uptake Value
Standard Deviation 2.2761
|
4.691 Standardized Uptake Value
Standard Deviation 2.6445
|
0.0506 Standardized Uptake Value
Standard Deviation 0.22251
|
SECONDARY outcome
Timeframe: Up to 8 weeks post contrast administration.Population: The variable is looking at the Overall Summary of Treatment-Emergent Adverse Events (TEAE). Subjects could have experienced more than one TEAE. The category titles refer to Severe Adverse Events(SAE) and Adverse Events (AE).
Safety was monitored throughout the duration of the subject's participation.
Outcome measures
| Measure |
Imaging Session 1
n=49 Participants
Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi \[370 megabecquerels (MBq)\]
|
Imaging Session 2
Fluciclatide Injection (AH111585 (18F) Injection)
|
Relative Difference
The Relative difference between imaging sessions 1 and 2.
|
|---|---|---|---|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Any TEAE
|
18 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Total number of TEAEs
|
47 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Any TEAE at least related to Drug
|
1 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Intesity-Mild
|
3 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Intensity-Moderate
|
8 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Intensity-Severe
|
7 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Any SAEs
|
7 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Any SAE at least related to Drug
|
0 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Any AE leading to Study Discontinuation
|
1 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Any AE leading to Death
|
2 number of adverse events
|
—
|
—
|
|
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.
Any AE leading to death at least related to Drug
|
0 number of adverse events
|
—
|
—
|
Adverse Events
1 Fluciclatide Injection
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Fluciclatide Injection
n=49 participants at risk
Fluciclatide Injection (AH111585 (18F) Injection)
|
|---|---|
|
Infections and infestations
Lower respiratory Tract Infection
|
2.0%
1/49 • Number of events 1 • Data was collected up to 8 weeks post contrast drug administration.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
1/49 • Number of events 1 • Data was collected up to 8 weeks post contrast drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma / Metastases
|
6.1%
3/49 • Number of events 3 • Data was collected up to 8 weeks post contrast drug administration.
|
|
Nervous system disorders
Spinal Cord Compression
|
2.0%
1/49 • Number of events 1 • Data was collected up to 8 weeks post contrast drug administration.
|
|
Surgical and medical procedures
Lymphadenectomy
|
2.0%
1/49 • Number of events 1 • Data was collected up to 8 weeks post contrast drug administration.
|
Other adverse events
| Measure |
1 Fluciclatide Injection
n=49 participants at risk
Fluciclatide Injection (AH111585 (18F) Injection)
|
|---|---|
|
General disorders
Asthenia
|
6.1%
3/49 • Number of events 3 • Data was collected up to 8 weeks post contrast drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place