Serial [18F]Thymidine (FLT)PET/CT as a Biomarker of Response in Pemetrexed Therapy for Non-Small Cell Lung Cancer

NCT02274038 | Terminated Results

• 1 other identifier: LC130313
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the hypothesis that positron emission tomography (PET) imaging with the imaging agent 18F-thymidine (FLT) can rapidly assess treatment response in patients with unresectable non-small cell lung cancer (NSCLC).

Conditions

Non-small Cell Lung Cancer; Starting Pemetrexed Based Therapy; Unresectable Cancer

Outcome Measures

Primary Outcomes (3)

• Baseline 18F-thymidine PET/CT (FLT-PET/CT)

  A baseline FLT-PET/CT will be performed prior to starting pemetrexed therapy. This scan will be used to compare to post therapy FLT-PET/CT in order to assess change in tumor accumulation of FLT.

  Prior to starting pemetrexed based therapy

• Post-therapy 18F-thymidine PET/CT (FLT-PET/CT) to Assess Flare Response

  FLT-PET/CT will be performed on the day of starting pemetrexed therapy. This scan will be used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT for evidence of an FLT "flare" response to pemetrexed therapy.

  On the day that pemetrexed therapy is started

• Post-therapy 18F-thymidine PET/CT (FLT-PET/CT) to Assess Tumor Proliferation Response

  FLT-PET/CT will be performed at approximately 2-4 weeks following the start of pemetrexed therapy. This scan will be used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT for evidence of a tumor proliferation response to pemetrexed therapy.

  Approximately 2-4 weeks following start of pemetrexed therapy.

Secondary Outcomes (2)

• Overall Survival

  1 year from study enrollment

• Progression-free Survival

  Within 1 year from study enrollment

Study Arms (1)

All patients will be enrolled in a single arm of the study

EXPERIMENTAL

All patients enrolled in the study will receive three 18F-thymidine (FLT) PET/CT scans at the following timepoints: before therapy, on the day of starting pemetrexed therapy (within 24 hours of starting pemetrexed) and at 2-4 weeks of starting pemetrexed therapy.

Drug: Baseline 18F-thymidine (FLT) PET/CT; Drug: Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced tumor FLT "flare"; Drug: Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced changes in tumor proliferation

Interventions

Baseline 18F-thymidine (FLT) PET/CT DRUG

FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This baseline scan will be used to compare post-therapy FLT-PET/CT in order to assess change in tumor accumulation of FLT.

All patients will be enrolled in a single arm of the study

Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced tumor FLT "flare" DRUG

FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This scan will be performed on the day of starting pemetrexed therapy (within 24hrs of starting pemetrexed) and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for early pemetrexed induced changes in tumor accumulation of FLT known as FLT "flare".

All patients will be enrolled in a single arm of the study

Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced changes in tumor proliferation DRUG

FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This scan will be performed 2-4 weeks after starting pemetrexed therapy and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for pemetrexed induced changes in tumor accumulation of FLT as a surrogate measure of tumor proliferation.

All patients will be enrolled in a single arm of the study

Eligibility Criteria

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

You may qualify if:

• Adult patients, at least 18 years of age
• Histologically confirmed non-small cell lung cancer with at least one site of disease \> 1 cm by at least one type of standard imaging (e.g. CT, chest x-ray, MRI)
• Recommended to start systemic therapy which includes pemetrexed and a platinum-based agent.
• Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
• Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.

You may not qualify if:

• Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
• Patients who have received chemotherapy within 2 weeks of enrollment will be excluded from the study.
• Patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded.
• Inability to tolerate imaging procedures in the opinion of the investigator or treating physician
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Sharyn Katz, Principal Investigator
• Organization: University of Pennsylvania Perelman School of Medicine

sharyn.katz@pennmedicine.upenn.edu

215-662-4000

Study Officials

• Sharyn I Katz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2014
• First Posted: October 24, 2014
• Study Start: March 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 12, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-05

Locations

US (1)