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Compares treatment options for Pilot Study
Official title A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Chronic Graft Versus Host Disease Manifestations
ClinicalTrials.gov ID: NCT07325253
What this study is testing
What is [18F]-4FN?
[18F]-4FN is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pilot study.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria
- Chronic GVHD involving the joints, defined as any limitation of range of motion measured by Photographic Range Of Motion (PROM). Criteria can be...
- Able to give written informed consent.
- ≥18 years of age
- Creatinine clearance ≥ 30 mL/min/1.73m2
You likely can't join if
- 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...
- Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F]4FN in pregnancy are not known.
- people with contraindications to the use of [18F]4FN including confirmed allergy.
- 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...
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may...
- Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.
See the full eligibility criteria
- Eligibility Criteria
- Chronic GVHD involving the joints, defined as any limitation of range of motion measured by Photographic Range Of Motion (PROM). Criteria can be found at (Jagasia, et al. 2015).
- Able to give written informed consent.
- ≥18 years of age
- Creatinine clearance ≥ 30 mL/min/1.73m2
- Non-joint chronic GVHD diagnostic / distinctive features are allowed.
- people may be planned to receive a new systemic therapy for chronic GVHD
- Prior/continuing systemic therapy for chronic GVHD is allowed
- KPS ≥ 20
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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.
- 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)
- Pregnant or lactating women: pregnant women are excluded from this study because the effects of [18F]4FN in pregnancy are not known.
- people with contraindications to the use of [18F]4FN including confirmed allergy.
- 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.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
- Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.