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Withdrawn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
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
- 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
NCT ID
NCT01610544
First Posted
May 31, 2012
Last Updated
July 3, 2018
Sponsor
National Cancer Institute (NCI)
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
Learn more about this trial
18F FLT Imaging Studies of Treatment Response for Lung Cancer and Thymoma
We'll reach out to this number within 24 hrs