A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Graft Versus Host Disease Manifestations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
Determine the spatial and temporal correlation between [18F]4FN PET/CT measurements and the clinical manifestations and severity of GVHD. We hypothesize that [18F]4FN PET/CT imaging features will anatomically and by intensity (SUV) correlate with concurrent GVHD manifestations. We also hypothesize that PET/CT imaging features will temporally precede GVHD manifestations at target anatomic locations.
Secondary Objective:
Identify the [18F]4FN PET/CT-positive GVHD lesions responsive to GVHD therapies. As a pharmacodynamic biomarker, we hypothesize that changes in [18F]4FN PET-positive GVHD lesions will correlate with treatments that target macrophages and neutrophils.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: George L Chen, MD
- Phone Number: 713-792-3630
- Email: glchen1@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- George L Chen, MD
- Phone Number: 713-792-3630
- Email: glchen1@mdanderson.org
-
Principal Investigator:
- George L Chen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Eligibility Criteria
- Acute or Chronic GVHD - acute and chronic GVHD criteria can be found at (Harris, Young et al. 2016)(Jagasia, et al. 2015).
- Able to give written informed consent.
- ≥18 years of age
- Creatinine clearance ≥ 30 mL/min/1.73m2
- Subjects may be planned to receive a new systemic therapy for acute or chronic GVHD
- Prior / continuing systemic therapy for acute or 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 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.
- 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
- 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.
- Subjects 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part 1
Prognostic Biomarker Analysis - [18F]4FN PET/CT at Baseline
|
Given by IV
Imaging
|
|
Experimental: Part 2
Predictive/PD Biomarker Analysis - [18F]4FN PET/CT before a New Systemic Therapy
|
Given by IV
Imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and adverse events (AEs).
Time Frame: Through study completion; an average of 1 year.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: George L Chen, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-1051
- NCI-2026-00037 (Other Identifier: NCI-CTRP Clinical Registr)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.