18F FLT Imaging Studies of Treatment Response for Lung Cancer and Thymoma

• Status: Withdrawn
• Trial end date: 2012-12-10
• Target enrollment: 0
• Participant gender: All

Summary

Background:

• Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans are used to detect tumor responses to cancer treatment. However, it may be difficult to detect early response to lung cancer or thymoma treatment with standard PET/CT scans. These scans cannot easily show a difference between remaining cancer cells and inflammation. Researchers want to try a new PET/CT scan tracer that may be able to show the difference between these cells. 18F-Fluorothymidine (18F-FLT) is better at showing which cells are still actively dividing. PET/CT scans with 18F-FLT may help show if tumor cells are responding to early stages of treatment.

Objectives:

• To see if 18F-FLT is a safe and effective imaging study tracer to show early cancer response to treatment.

Eligibility:

• Individuals at least 18 years of age who are being treated for lung cancer or thymoma.

Design:

• Participants will be screened with a physical exam and medical history. Blood, urine, and tumor tissue samples will be collected.

• Participants will have two PET/CT scans on separate days before starting chemotherapy. One scan will be with a standard radiotracer. The other will be with the 18F-FLT tracer.

• About 2 weeks after starting chemotherapy, participants will repeat the two PET/CT scans on separate days. Additional blood samples will be collected at this time.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alovudine

Criteria

• INCLUSION CRITERIA:

• Subjects with pathology proven lung cancer or thymic malignancy already enrolled in an NCI treatment protocol usingAZD6244 in NSCLC and IMC-A12, in thymoma.

• Participant must be 18 years or older

• ECOG Performance score of 0 to 2

• Ability to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of this study before any protocol related studies are performed.

• Participants must NOT be pregnant or intend to become pregnant within 1 week of the last injection of (18)F FLT

EXCLUSION CRITERIA:

• Known allergy to fluorothymidine

• Participants for whom enrollment would significantly delay (> 2 weeks) the scheduled standard of care therapy

• Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded

• Participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing >136 kg (weight limit for scanner table)

• Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures