Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Eligibility Criteria

1. 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).

2. Able to give written informed consent.

3. ≥18 years of age

4. Creatinine clearance ≥ 30 mL/min/1.73m2

5. Non-joint chronic GVHD diagnostic / distinctive features are allowed.

6. Subjects may be planned to receive a new systemic therapy for chronic GVHD

7. Prior/continuing systemic therapy for chronic GVHD is allowed

8. ECOG performance status ≤2

9. Ability to understand and the willingness to sign a written informed consent
document.

10. 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.

- 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.

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1
Prognostic Biomarker Analysis - [18F]4FN PET/CT at Baseline
  • Drug: [18F]-4FN
    Given by IV
  • Other: PET-CT
    Imaging
Experimental
Part 2
Predictive/PD Biomarker Analysis - [18F]4FN PET/CT before a New Systemic Therapy
  • Drug: [18F]-4FN
    Given by IV
  • Other: PET-CT
    Imaging

Recruiting Locations

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
George L Chen, MD
713-792-3630
glchen1@mdanderson.org

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

George L Chen, MD
713-792-3630
glchen1@mdanderson.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.