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[18F]F-AraG Detection for Graft-versus-Host Disease

Phase 1

Recruiting

Led By Sanjiv Gambhir, M.D,, Ph.D.

Research Sponsored by CellSight Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be 21 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of the follow up will extend to 6 months post final scan for all agvhd subjects by chart review.

Awards & highlights

Study Summary

This trial is testing whether a PET scan using a tracer called [18F]F-AraG can help identify sites of Graft Versus Host Disease (GVHD) in patients who are likely to have the disease or are at high risk of developing it.

Who is the study for?

This trial is for adults over 21 suspected of having acute Graft Versus Host Disease (GVHD) needing treatment, or at high risk for GVHD after certain stem cell transplants. Healthy volunteers must have no medical issues affecting the scan results. Pregnant/nursing individuals, those with substance abuse, uncontrolled infections, relapsed malignancy, or current immunotherapy are excluded.Check my eligibility

What is being tested?

[18F]F-AraG PET scans are being tested to detect and predict acute GVHD by imaging T cell accumulation in patients. The study will compare scan results with biopsy findings in patients suspected of having GVHD and monitor high-risk patients to assess predictive value.See study design

What are the potential side effects?

As [18F]F-AraG is used for imaging purposes in this trial, side effects may include discomfort from the injection site or allergic reactions to the tracer. However, specific side effects related to [18F]F-AraG are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of the follow up will extend to 6 months post final scan for all agvhd subjects by chart review.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of the follow up will extend to 6 months post final scan for all agvhd subjects by chart review.

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the follow up will extend to 6 months post final scan for all agvhd subjects by chart review. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of aGVHD

Severity/score of aGVHD

Secondary outcome measures

Healthy subject

Trial Design

3Treatment groups

Experimental Treatment

Group I: Highly suspected to already have aGVHDExperimental Treatment1 Intervention

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

Group II: High risk of developing aGVHDExperimental Treatment1 Intervention

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.

Group III: Healthy SubjectsExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CellSight Technologies, Inc.Lead Sponsor

17 Previous Clinical Trials

281 Total Patients Enrolled

Stanford UniversityOTHER

2,395 Previous Clinical Trials

17,341,565 Total Patients Enrolled

Sanjiv Gambhir, M.D,, Ph.D.Principal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has [18F]F-Ara-G received authorization by the Food and Drug Administration?

"The [18F]F-Ara-G has been given an appraisal of 1, as the current trial is a Phase 1. This classification implies that there is only limited data proving its safety and efficacy."

Answered by AI

What is the uppermost limit for enrollment in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov reveals that this trial, which was originally posted in May of 2018, is looking for participants right now. The study will be recruiting 30 individuals at a single facility."

Answered by AI

Is this trial currently in search of participants?

"Affirmative, according to clinicaltrials.gov this investigation is enrolling participants at present. It was first published on May 15th 2018 and modified most recently on March 7th 2022. 30 people need to be enlisted from one site for the study's success."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Detection of Graft Versus Host Disease With [18F]F-AraG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03367962.

All > Graft Vs Host Disease