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

Sponsor
CellSight Technologies, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03367962
Collaborator
Stanford University (Other)
30
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3
61.2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Detection of Graft Versus Host Disease With [18F]F-AraG, a Positron Emission Tomography Tracer for Activated T Cells
Actual Study Start Date :
May 15, 2018
Anticipated Primary Completion Date :
Jun 21, 2023
Anticipated Study Completion Date :
Jun 21, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Severity/score of aGVHD [Duration of the follow up will extend to 6 months post final scan for all aGVHD subjects by chart review.]

    Primary outcome will be the severity/score of aGVHD in the highly suspected group.

  2. Development of aGVHD [Duration of the follow up will extend to 6 months post final scan for all aGVHD subjects by chart review.]

    Primary outcome will be the development of aGVHD in the high risk group.

Secondary Outcome Measures

  1. Healthy subject [Follow up will occur 2 to 7 days post scan.]

    Biodistribution information and kinetic behavior of the radiotracer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

  3. For patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis.

  4. For patients at high risk for developing aGVHD, informed consent should be signed prior to transplant.

  5. 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.

  6. For patients highly suspected to have aGVHD and requiring systemic therapy only: Taking steroid treatment for suspected aGVHD for 3 days or less.

  7. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Hospital Stanford California United States 94305

Sponsors and Collaborators

  • CellSight Technologies, Inc.
  • Stanford University

Investigators

  • Principal Investigator: Sanjiv Gambhir, M.D,, Ph.D., Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CellSight Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT03367962
Other Study ID Numbers:
  • IRB_38850
First Posted:
Dec 11, 2017
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CellSight Technologies, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022