Trial Outcomes & Findings for Detection of Graft Versus Host Disease With [18F]F-AraG (NCT NCT03367962)
NCT ID: NCT03367962
Last Updated: 2025-12-08
Results Overview
Acute GVHD severity was graded using the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Grades I-IV). Grades were assigned based on organ involvement documented in the clinical chart and biopsy review at the time of the PET/CT scan. We reported the number of participants within each grade.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
At the time of the PET/CT scan: within 7 days of GVHD suspicion for the Highly Suspected arm, and at the Day 4 ± 2 post-transplant scan for the High-Risk arm
Results posted on
2025-12-08
Participant Flow
Participant milestones
| Measure |
Highly Suspected to Already Have aGVHD
Patients highly suspected to have aGVHD. These patients will undergo a \[18F\]F-AraG PET-CT scan following a biopsy taken to confirm aGVHD.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
High Risk of Developing aGVHD
Patients at high risk of developing aGVHD will undergo a \[18F\]F-AraG PET-CT scan on day 4 +/- 2 days post transplant. Additionally these patients will be scanned again between day 14-21 post transplant.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
Healthy Subjects
Healthy subject volunteers will undergo preliminary evaluation to ensure eligibility, receive and sign an informed consent, be enrolled in the trial, and then have a \[18F\]F-AraG PET-CT scan.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
0
|
|
Overall Study
COMPLETED
|
6
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Detection of Graft Versus Host Disease With [18F]F-AraG
Baseline characteristics by cohort
| Measure |
Highly Suspected to Already Have aGVHD
n=7 Participants
Patients highly suspected to have aGVHD. These patients will undergo a \[18F\]F-AraG PET-CT scan following a biopsy taken to confirm aGVHD.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
High Risk of Developing aGVHD
n=2 Participants
Patients at high risk of developing aGVHD will undergo a \[18F\]F-AraG PET-CT scan on day 4 +/- 2 days post transplant. Additionally these patients will be scanned again between day 14-21 post transplant.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
Healthy Subjects
Healthy subject volunteers will undergo preliminary evaluation to ensure eligibility, receive and sign an informed consent, be enrolled in the trial, and then have a \[18F\]F-AraG PET-CT scan.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=175 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=175 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
9 Participants
n=175 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
5 Participants
n=175 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
4 Participants
n=175 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=175 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
8 Participants
n=175 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=175 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
3 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=175 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
4 Participants
n=175 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=175 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=37 Participants
|
2 participants
n=37 Participants
|
—
|
9 participants
n=175 Participants
|
PRIMARY outcome
Timeframe: At the time of the PET/CT scan: within 7 days of GVHD suspicion for the Highly Suspected arm, and at the Day 4 ± 2 post-transplant scan for the High-Risk armAcute GVHD severity was graded using the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Grades I-IV). Grades were assigned based on organ involvement documented in the clinical chart and biopsy review at the time of the PET/CT scan. We reported the number of participants within each grade.
Outcome measures
| Measure |
Healthy Subjects
n=6 Participants
Healthy subject volunteers will undergo preliminary evaluation to ensure eligibility, receive and sign an informed consent, be enrolled in the trial, and then have a \[18F\]F-AraG PET-CT scan.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
High Risk of Developing aGVHD
n=2 Participants
Patients at high risk of developing aGVHD will undergo a \[18F\]F-AraG PET-CT scan on day 4 +/- 2 days post transplant. Additionally these patients will be scanned again between day 14-21 post transplant.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
|---|---|---|
|
Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan
Grade 0
|
0 Participants
|
2 Participants
|
|
Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan
Grade 1
|
0 Participants
|
0 Participants
|
|
Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan
Grade 2
|
4 Participants
|
0 Participants
|
|
Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan
Grade 3
|
1 Participants
|
0 Participants
|
|
Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan
Grade 4
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From PET/CT scan to 6 months post-scan.All participants were followed for 6 months post-imaging. Development of GVHD was defined by clinical diagnosis documented in the medical record..
Outcome measures
| Measure |
Healthy Subjects
n=6 Participants
Healthy subject volunteers will undergo preliminary evaluation to ensure eligibility, receive and sign an informed consent, be enrolled in the trial, and then have a \[18F\]F-AraG PET-CT scan.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
High Risk of Developing aGVHD
n=2 Participants
Patients at high risk of developing aGVHD will undergo a \[18F\]F-AraG PET-CT scan on day 4 +/- 2 days post transplant. Additionally these patients will be scanned again between day 14-21 post transplant.
\[18F\]F-Ara-G: the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
|
|---|---|---|
|
Number of Participants Who Developed aGVHD Within 6 Months Post-Scan.
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Follow up will occur 2 to 7 days post scan.Population: No healthy volunteers were imaged due to loss of study funding; therefore, no data were collected for this outcome.
This outcome was intended to assess biodistribution and kinetic behavior of \[18F\]F-AraG in healthy adult volunteers. However, no healthy volunteers were imaged due to funding limitations.
Outcome measures
Outcome data not reported
Adverse Events
Highly Suspected to Already Have aGVHD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk of Developing aGVHD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place