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

Primary Purpose

Graft Versus Host Disease

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

[18F]F-Ara-G

About this trial

This is an interventional diagnostic trial for Graft Versus Host Disease focused on measuring PET-CT scan, [18F]F-AraG

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.
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.
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:

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

Sites / Locations

Stanford HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Highly suspected to already have aGVHD

High risk of developing aGVHD

Healthy Subjects

Arm Description

Patients highly suspected to have aGVHD. These patients will undergo a [18F]F-AraG PET-CT scan following a biopsy taken to confirm 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.

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.

Outcomes

Primary Outcome Measures

Severity/score of aGVHD

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

Development of aGVHD

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

Secondary Outcome Measures

Healthy subject

Biodistribution information and kinetic behavior of the radiotracer.

Full Information

NCT ID

NCT03367962

First Posted

December 5, 2017

Last Updated

October 3, 2023

Sponsor

CellSight Technologies, Inc.

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03367962

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2018 (Actual)

Primary Completion Date

June 21, 2023 (Actual)

Study Completion Date

October 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CellSight Technologies, Inc.

Collaborators

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft Versus Host Disease

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Highly suspected to already have aGVHD

Arm Type

Experimental

Arm Description

Patients highly suspected to have aGVHD. These patients will undergo a [18F]F-AraG PET-CT scan following a biopsy taken to confirm aGVHD.

Arm Title

High risk of developing aGVHD

Arm Type

Experimental

Arm Description

Arm Title

Healthy Subjects

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

[18F]F-Ara-G

Intervention Description

the [18F]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.

Primary Outcome Measure Information:

Title

Severity/score of aGVHD

Description

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

Time Frame

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

Title

Development of aGVHD

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Healthy subject

Description

Biodistribution information and kinetic behavior of the radiotracer.

Time Frame

Follow up will occur 2 to 7 days post scan.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jordan Cisneros

Phone

(650)-725-6409

jordan.cisneros@stanford.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Krithika Rupnarayan, MPH

Phone

(650)-736-0959

krupnara@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjiv Gambhir, M.D,, Ph.D.

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Hospital

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krithika Rupnarayan, MPH,MBBS

Phone

650-736-0959

krupnara@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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