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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01610544
First received: May 31, 2012
Last updated: May 3, 2013
Last verified: December 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Thymus Neoplasms
 Drug: 3'-deoxy-3'-18F fluorothymidine (FLT)
Other: PET/CT scan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of 18F FLT PET/CT in Evaluating Early Response to Anti-Proliferative Therapies in Non Small Cell Lung Cancer and Thymic Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 0
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 3'-deoxy-3'-18F fluorothymidine (FLT)
    N/A
    Other: PET/CT scan
    N/A
Detailed Description:

Background:

  • (18)F FLT, a thymidine analog, has uptake in tumors that correlates with proliferative rates and may be an early predictor of tumor response.
  • Due to uptake in inflammatory tissues, routinely used (18)F FDG PET/CT is often unable to distinguish therapeutic response from reactive change early in therapy.
  • Molecularly targeted therapies relating to the MEK kinase pathway in non small cell lung cancer (NSCLC) and the IGF pathway (anti-IGF-1R monoclonal antibodies) in thymoma, affect tumor proliferation.
  • We intend to explore the potential utility of (18)F FLT PET/CT imaging as an early marker of therapeutic response in molecularly targeted therapies relating to the MEK kinase pathway in NSCLC and the IGF pathway in thymic tumors.

Objectives:

-To explore the relationship between change in (18)F FLT tumor uptake (pre-treatment and soon after initiation of treatment (2 weeks)) and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

Eligibility:

  • Subjects with pathology proven lung cancer or thymoma enrolled in an NCI therapy protocol.
  • Participant must be 18 years or older and have ECOG Performance of less than or equal to 2.
  • Patients must have measurable disease by RECIST criteria.
  • Patients must have the ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

Design:

-This is a pilot study which will incorporate (18)F FLT and (18)F FDG PET/CT imaging sessions prior to therapy with AZD6244, Selumetinib, in NSCLC and IMC-A12, Cixutumumab, in thymoma, and 2 weeks (+/- 4 days) following therapy initiation. The imaging parameters will be evaluated with respect to clinical response (as determined under the referring protocol). We expect to enroll 24 evaluable patients in this single center study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610544

Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Maria Liza Lindenberg, M.D. National Cancer Institute (NCI)
  More Information

Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01610544     History of Changes
Other Study ID Numbers: 120130, 12-C-0130
Study First Received: May 31, 2012
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Thymoma
Insulin Growth Factor
Cell Proliferation
Non Small Cell Lung Cancer
PET/CT Imaging Sessions

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013