Trials Today

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.