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PET Imaging of the Immune System Using Analog Probes

NCT03409419 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2021-10-12

No results posted yet for this study

Summary

The goal of this proposal is to assess the biodistribution of 18F-Clofarabine, a new tracer developed for use in PET/CT scans. The investigator's hypothesis is this tracer will allow for imaging immune activation in patients with melanoma before and after treatment with immunotherapy.

A maximum of 10 subjects are intended to be included in this study. Each subject will undergo a maximum of two 18F-Clofarabine PET/CT scans, with each visit taking up to 4 hours. The first visit will be prior to the first cycle of immunotherapy treatment, and the second scan will take place 2-4 weeks after the immunotherapy treatment has started.

Prior to the PET scan an IV line will be placed. Blood pressure, heart rate, blood oxygen and ECG will be obtained. Then the 18F-Clofarabine will be injected and the PET/CT scan acquisition started. After a maximum of 120 min of scanning, subjects will undergo again blood pressure, heart rate, blood oxygen and ECG.

Conditions

  • Malignant Melanoma

Interventions

DRUG

[18F] CFA

pilot study to evaluate the bio-distribution of \[18F\] CFA, a new tracer for imaging the purine nucleoside biosynthetic pathway, before and after immunotherapy treatment in patients with metastatic or recurrent advanced melanoma.

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Antoni Ribas, M.D. · UCLA/Jonsson Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2020-11-10
Completion
2020-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409419 on ClinicalTrials.gov