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

NCT01610544 | Withdrawn Phase 2

• 2 other identifiers: 12013012-C-0130
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung; Thymus Neoplasms

Keywords

Thymoma; Insulin Growth Factor; Cell Proliferation; Non Small Cell Lung Cancer; PET/CT Imaging Sessions

Outcome Measures

Primary Outcomes (1)

• To explore the relationship between change in 18F FLT tumor uptake and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

Secondary Outcomes (2)

• To explore the relationship between the absolute pre-treatment 18F FLT uptake and the clinical response to therapy

• To determine if the change in 18F FLT uptake is different from the change in 18F FDG PET/CT at the same time points

Interventions

3'-deoxy-3'-18F fluorothymidine (FLT) DRUG

PET/CT scan OTHER

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Related Publications (3)

• McKian KP, Haluska P. Cixutumumab. Expert Opin Investig Drugs. 2009 Jul;18(7):1025-33. doi: 10.1517/13543780903055049.

  PMID: 19548856 BACKGROUND

• Shields AF, Mankoff DA, Link JM, Graham MM, Eary JF, Kozawa SM, Zheng M, Lewellen B, Lewellen TK, Grierson JR, Krohn KA. Carbon-11-thymidine and FDG to measure therapy response. J Nucl Med. 1998 Oct;39(10):1757-62.

  PMID: 9776283 BACKGROUND

• Vesselle H, Grierson J, Muzi M, Pugsley JM, Schmidt RA, Rabinowitz P, Peterson LM, Vallieres E, Wood DE. In vivo validation of 3'deoxy-3'-[(18)F]fluorothymidine ([(18)F]FLT) as a proliferation imaging tracer in humans: correlation of [(18)F]FLT uptake by positron emission tomography with Ki-67 immunohistochemistry and flow cytometry in human lung tumors. Clin Cancer Res. 2002 Nov;8(11):3315-23.

  PMID: 12429617 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Thymus Neoplasms; Thymoma; Hyperplasia

Interventions

alovudine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Liza Lindenberg, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: May 10, 2012
• Primary Completion: December 10, 2012
• Study Completion: December 10, 2012
• Last Updated: July 5, 2018

Record last verified: 2012-12-10