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| ID | Type | Description | Link |
|---|---|---|---|
| 5P01CA049605 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| National Cancer Institute (NCI) | NIH |
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This is a single-center imaging study to determine utility of in vivo imaging with [18F]F-AraG to identify sites of Graft Versus Host Disease (GVHD) in patients highly suspected of having acute GVHD who require systemic therapy, and patients at high risk for developing acute GVHD. [18F]F-AraG PET scans will be compared to biopsy results to correlate T cell accumulation which is implicated in the disease. High risk patients will be followed to verify predictive potential of [18F]F-AraG.
This single-center imaging study will enroll three cohorts of participants: healthy volunteers, patients highly suspected to have acute GVHD (aGVHD) and requiring systemic therapy, and patients at high risk for developing GVHD.
A total of 5 healthy volunteers will undergo [18F]F-AraG PET scans and blood sampling to better understand [18F]F-AraG biodistribution and stability in the body.
A total of 10 highly suspected acute GVHD patients will be scanned following biopsy taken to confirm aGVHD. The staging and grading of the disease using the Glucksberg grade and International Bone Marrow Transplant Registry Severity Index (IBMTR) at time of enrollment will be noted. Biopsy tissues of consented patients will be analyzed further for T cell involvement.
A total of 15 high-risk patients (recipients of myeloablative or reduced intensity allogeneic transplants using either bone marrow or peripheral blood stem cells from HLA-matched or HLA-mismatched related or unrelated donors-protocols 9142, 9022, 9924) will be recruited. All those that consent will undergo a PET-CT scan with [18F]FAraG on day 4 +/- 2 days post transplant. Additionally, these patients will be scanned again between day 14-21 post transplant. Follow up on these patients will note those that go on to develop aGVHD and the clinical end point will be correlated to the scans to verify the predictive potential of the radiotracer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Highly suspected to already have aGVHD | Experimental | Patients highly suspected to have aGVHD. These patients will undergo a [18F]F-AraG PET-CT scan following a biopsy taken to confirm aGVHD. |
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| High risk of developing aGVHD | Experimental | 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. |
|
| Healthy Subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]F-Ara-G | Drug | the [18F]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan | 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. | 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 |
| Number of Participants Who Developed aGVHD Within 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.. | From PET/CT scan to 6 months post-scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution and Kinetic Behavior of [18F]F-AraG in Healthy Volunteers | 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. | Follow up will occur 2 to 7 days post scan. |
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Inclusion Criteria:
Must be 21 years of age or older.
Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
For healthy volunteers only: Must have no known medical problems that would make undergoing the scan hazardous to the health of the patient or interfere with the results. In particular subjects should not have any cardiac or immunological disorders as these would likely affect the scan results. Subjects should have had a full physical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures.
For patients highly suspected to have aGVHD and requiring systemic therapy only: Taking steroid treatment for suspected aGVHD for 3 days or less.
For patients at high risk for developing aGVHD only: Recipients of myeloablative or reduced intensity allogeneic transplants using either bone marrow or peripheral blood stem cells from HLA-matched or HLA-mismatched related or unrelated donors (protocols 9142, 9022, 9924) who have not yet been placed on any therapy for acute GVHD.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Negrin, M.D.. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Ran out of funding for Healthy Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan | 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. | Posted | Count of Participants | Participants | 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 |
|
Up to 7 days after the single tracer infusion in the "Highly Suspected to Already Have aGVHD" Arm and up to 7 days after the first and final scan in the "High Risk of Developing aGVHD" Arm".
No participants experienced adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Negrin | Stanford University | 6507230822 | negrs@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 29, 2020 | Dec 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
|
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| Primary | Number of Participants Who Developed aGVHD Within 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.. | Posted | Count of Participants | Participants | From PET/CT scan to 6 months post-scan. |
|
|
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| Secondary | Biodistribution and Kinetic Behavior of [18F]F-AraG in Healthy Volunteers | 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. | No healthy volunteers were imaged due to loss of study funding; therefore, no data were collected for this outcome. | Posted | Follow up will occur 2 to 7 days post scan. |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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