Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET

NCT01065818 | Terminated Results DMC

• 2 other identifiers: AAAD5444R21CA121551
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to better detect changes of tumor growth rate (or how active) in esophagus cancer and lung cancer Researchers will study at what time during treatment the 18F-FLT PET scan should be given to get the best results. A Positron Emission Tomography (PET) scan is a type of scan that uses a radioactive solution to locate cancer cells inside the body. Using the PET scan, doctors can locate solid tumors and collect information about how "active" the cancer cells are. For this study, a new type of solution, \[F-18\]-fluoro-L-thymidine (FLT), will be used. FLT can detect actively growing tumor, and researchers hope that FLT may be able to help provide information about how well esophagus cancer treatment is working. This information could be used to help predict if the cancer will respond to treatment. All enrolled subjects will receive PET/CT imaging at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy (3 weeks from the start of Neoadjuvant Therapy) prior to the surgery. At each time of the PET/CT procedure, the subject will receive an injection of FLT which is an investigational pharmaceutical labeled with radioactive fluorine. 45-60 mines after the FLT injection, the scan will be performed. Each scan might take 10-15 minutes. Participation in this pilot study will not change the patients normal chemotherapy, radiation treatment, and surgery recommended the patients physician as parts of their standard of care.

Conditions

Esophageal Cancer; Non-small Cell Lung Cancer

Keywords

Esophageal cancer; Non-small cell lung cancer; FLT-PET; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response

  2.5 months

Study Arms (1)

Fluoro-L-Thymidine

EXPERIMENTAL

Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.

Drug: Fluoro-L-Thymidine

Interventions

Fluoro-L-Thymidine DRUG

4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.

Also known as: FLT

Fluoro-L-Thymidine

Eligibility Criteria

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

You may qualify if:

• Patients with histologically diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus and locoregional disease (stages II and III) and locally advanced non-small cell lung cancer (stage III) will be eligible for participation in this study.

You may not qualify if:

• Abnormal liver function (\<2.5 x ULN of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ; \<1.5 x upper limit of normal (ULN) of bilirubin total) or abnormal renal function (\<1.5 x ULN of creatinine) or peripheral neuropathy
• Women with pregnancy or breastfeeding

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Enrollment was very slow and poor, resulting in inadequate data collection. As a result, data was not analyzed.

Results Point of Contact

• Title: K.S. Clifford Chao, MD
• Organization: Columbia University

ksc2119@cumc.columbia.edu

212-305-9987

Study Officials

• K.S. Clifford Chao, MD

  Columbia University

  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: February 8, 2010
• First Posted: February 9, 2010
• Study Start: August 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 26, 2017
• Results First Posted: September 26, 2017

Record last verified: 2017-08

Locations

US (1)