A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Graft Versus Host Disease Manifestations
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
[18F]-4FN
DrugGiven by IV
PET-CT
Other interventionImaging
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Part 1Experimental treatment 2 interventions
Group B: Part 2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov