A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Chronic Graft Versus Host Disease Manifestations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-18

Study Completion Date

2030-01-03

Brief Summary

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To study the safety and possible side effects of using the imaging agent 4-\[18F\]Fluoro-1-Naphthol (also called \[18F\]4FN) in PET/CT scans for participants with chronic GVHD.

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Detailed Description

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Primary Objective

Determine the spatial and temporal correlation between \[18F\]4FN PET/CT measurements and the clinical manifestations and severity of chronic GVHD. We hypothesize that \[18F\]4FN PET/CT imaging features will anatomically and by intensity (SUV) correlate with concurrent chronic GVHD manifestations. We also hypothesize that PET/CT imaging features will temporally precede chronic GVHD manifestations at target anatomic locations.

Conditions

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Pilot Study PET/CT Imaging Host Disease Manifestation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Part 1

Prognostic Biomarker Analysis - \[18F\]4FN PET/CT at Baseline

Group Type EXPERIMENTAL

[18F]-4FN

Intervention Type DRUG

Given by IV

PET-CT

Intervention Type OTHER

Imaging

Part 2

Predictive/PD Biomarker Analysis - \[18F\]4FN PET/CT before a New Systemic Therapy

Group Type EXPERIMENTAL

[18F]-4FN

Intervention Type DRUG

Given by IV

PET-CT

Intervention Type OTHER

Imaging

Interventions

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[18F]-4FN

Given by IV

Intervention Type DRUG

PET-CT

Imaging

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Postmenopausal (no menses in greater than or equal to 12 consecutive months).
* History of hysterectomy or bilateral salpingo-oophorectomy.
* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
* History of bilateral tubal ligation or another surgical sterilization procedure.

* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
11. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration.

1. Unable to comply with all study procedures (for example, participants who are unable to come to all follow up visits because they live far away from the transplant center)
2. Pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18F\]4FN in pregnancy are not known.
3. Subjects with contraindications to the use of \[18F\]4FN including confirmed allergy.
4. Participants with a body weight of 400 pounds or more, or a body habitus which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight.
5. Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
6. Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No