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

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Thymus Neoplasms

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
3'-deoxy-3'-18F fluorothymidine (FLT)
PET/CT scan
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Non-Small-Cell Lung focused on measuring Thymoma, Insulin Growth Factor, Cell Proliferation, Non Small Cell Lung Cancer, PET/CT Imaging Sessions

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    May 31, 2012
    Last Updated
    July 3, 2018
    Sponsor
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01610544
    Brief Title
    18F FLT Imaging Studies of Treatment Response for Lung Cancer and Thymoma
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 10, 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 10, 2012 (undefined)
    Primary Completion Date
    December 10, 2012 (Actual)
    Study Completion Date
    December 10, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small-Cell Lung, Thymus Neoplasms
    Keywords
    Thymoma, Insulin Growth Factor, Cell Proliferation, Non Small Cell Lung Cancer, PET/CT Imaging Sessions

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    3'-deoxy-3'-18F fluorothymidine (FLT)
    Intervention Type
    Other
    Intervention Name(s)
    PET/CT scan
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    To explore the relationship between the absolute pre-treatment 18F FLT uptake and the clinical response to therapy
    Title
    To determine if the change in 18F FLT uptake is different from the change in 18F FDG PET/CT at the same time points

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Liza Lindenberg, M.D.
    Organizational Affiliation
    National Cancer Institute (NCI)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19548856
    Citation
    McKian KP, Haluska P. Cixutumumab. Expert Opin Investig Drugs. 2009 Jul;18(7):1025-33. doi: 10.1517/13543780903055049.
    Results Reference
    background
    PubMed Identifier
    9776283
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12429617
    Citation
    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.
    Results Reference
    background

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

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