Detection of Graft Versus Host Disease With [18F]F-AraG

Detection of Graft Versus Host Disease With [18F]F-AraG, a Positron Emission Tomography Tracer for Activated T Cells

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.

Study Overview

• Status: Completed
• Conditions: Graft Versus Host Disease
• Intervention / Treatment: Drug: [18F]F-Ara-G

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Must be 21 years of age or older.

2. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.

   1. For patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis.
   2. For patients at high risk for developing aGVHD, informed consent should be signed prior to transplant.
3. 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.
4. For patients highly suspected to have aGVHD and requiring systemic therapy only: Taking steroid treatment for suspected aGVHD for 3 days or less.
5. 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:

1. Pregnant or nursing
2. Individuals with known or suspected substance abuse, obtained by self-reporting.
3. Uncontrolled infection
4. Relapsed/persistent malignancy
5. Currently receiving immunotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: [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.
Experimental: 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.	Drug: [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.
Experimental: 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.	Drug: [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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: CellSight Technologies, Inc.
• Collaborators: National Cancer Institute (NCI); Stanford University
• Investigators: Principal Investigator: Robert Negrin, M.D.., Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): October 21, 2023

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: PET-CT scan; [18F]F-AraG
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: IRB_38850; 5P01CA049605 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No