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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-00037 | Other Identifier | NCI-CTRP Clinical Registr |
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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.
Primary Objective:
Determine the spatial and temporal correlation between [18F]4FN PET/CT measurements and the clinical manifestations and severity of chronic GVHD. Investigators hypothesize that [18F]4FN PET/CT imaging features will anatomically and by intensity (SUV) correlate with concurrent chronic GVHD manifestations. Investigators also hypothesize that PET/CT imaging features will temporally precede chronic GVHD manifestations at target anatomic locations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Prognostic Biomarker Analysis - [18F]4FN PET/CT at Baseline |
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| Part 2 | Experimental | Predictive/PD Biomarker Analysis - [18F]4FN PET/CT before a New Systemic Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-4FN | Drug | Given by IV |
| |
| PET-CT |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs). | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |
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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.
Subjects 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; 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 participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant 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.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George L Chen, MD | Contact | 713-792-3630 | glchen1@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| George L Chen, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Other |
Imaging |
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