New PET scan agent may spot hidden GVHD in joints
NCT ID NCT07325253
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 8 times
Summary
This pilot study is testing a new imaging agent called [18F]4FN in PET/CT scans for people with chronic graft-versus-host disease (GVHD) affecting their joints. The goal is to see if the agent is safe and can help doctors see joint problems more clearly. Sixteen adults with chronic GVHD will receive the agent by IV and then have a PET/CT scan. The study focuses on safety and how well the imaging works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]4FN (an imaging agent given by IV)
- What this could lead to
- If successful, this could lead to a better way to see and measure chronic GVHD in joints using PET/CT scans, helping doctors diagnose and monitor the condition more accurately.
- What could go wrong
- This is a very small, early pilot study with only 16 participants, so results may not apply to everyone. The main goal is safety and feasibility, not yet proving the imaging works for diagnosis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Eligibility Criteria 1. Acute or Chronic GVHD - acute and chronic GVHD criteria can be found at (Harris, Young et al. 2016)(Jagasia, et al. 2015). 2. Able to give written informed consent. 3. ≥18 years of age 4. Creatinine clearance ≥ 30 mL/min/1.73m2 5. Subjects may be planned to receive a new systemic therapy for GVHD 6. Prior / continuing systemic therapy for acute or chronic GVHD is allowed 7. KPS ≥ 20 8. Ability to understand and the willingness to sign a written informed consent document. 9. The effects of the study agent on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * 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. 10. 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. Exclusion Criteria 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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- Can a new pill outperform standard care for a tough transplant complication?
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