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

NCT03367962 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: IRB_388505P01CA049605
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft Versus Host Disease

Keywords

PET-CT scan; [18F]F-AraG

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Biodistribution and Kinetic Behavior of [18F]F-AraG in Healthy Volunteers

  Follow up will occur 2 to 7 days post scan.

Study Arms (3)

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.

Drug: [18F]F-Ara-G

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.

Drug: [18F]F-Ara-G

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.

Drug: [18F]F-Ara-G

Interventions

[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.

Healthy Subjects; High risk of developing aGVHD; Highly suspected to already have aGVHD

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis.
• For patients at high risk for developing aGVHD, informed consent should be signed prior to transplant.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• CellSight Technologies, Inc.: lead
• Stanford University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Dr. Robert Negrin
• Organization: Stanford University

negrs@stanford.edu

6507230822

Study Officials

• Robert Negrin, M.D..

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: May 15, 2018
• Primary Completion: June 21, 2023
• Study Completion: October 21, 2023
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)