Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET

Non-small Cell Lung Cancer Clinical Trial

Official title:

Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01065818
• Other study ID #: AAAD5444
• Secondary ID: R21CA121551
• Status: Terminated
• Phase: N/A
• First received: February 8, 2010
• Last updated: August 28, 2017
• Start date: August 2009
• Est. completion date: February 2013

Study information

• Verified date: August 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of the study is to obtain preliminary data and initial estimates of the FLT ability-PET to identify pathCR patients who have esophageal carinoma or non-small cell lung cancer and undergo Neoadjuvant Therapy (Chemoradiotherapy, Chemotherapy or Radiation Therapy) prior to surgery. Achievement in pathCR after pre-operative Neoadjuvant Therapy is associated with improved patient outcomes; however, there is no effective method to predict pathological response before surgery. Thus, a patient with pathCR , for whom esophagectomy or thoracoscopy may be unnecessary, still undergoes surgery and faces the prohibitive side effects of this surgical procedure. Additionally, Neoadjuvant Therapy is associated with considerable morbidities and tool to predict and avoid ineffective therapy are lacking. Because deregulated proliferation is one of the hallmarks of cancer and its proliferation rate is associated with aggressive biologic behavior and response to therapy, imaging the proliferative state of cancer cells by non-invasive functional imaging is of great interest. Recently 18F-FLT (3'deoxy33'-18F- fluorothymidine) has been reported as a promising PET radiopharmaceutical for imaging cancer proliferation and has been validated in several in vitro & in vivo models. However, only a few studies addressed its role in depicting changes in cancer proliferation and assessing response to Neoadjuvant Therapy, and none of these studies have focused on esophageal cancer and lung cancer. We propose to conduct a pilot study to learn the optimal FLT PET imaging timepoint during the early course of Neoadjuvant Therapy that has the highest predictive value for pathCR in patients with esophageal cancer or lung cancer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Esophageal Cancer
• Esophageal Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response		2.5 months