FLT PET/CT for Staging, Target Definition and Assessment of Response to Therapy in Patients With Esophageal Cancer

This study is ongoing, but not recruiting participants.
Brigham and Women's Hospital
Information provided by (Responsible Party):
Harvey Mamon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
First received: September 30, 2010
Last updated: August 27, 2015
Last verified: August 2015

The purpose of this pilot study is to develop a more advanced software program that will collect, compare and analyze tumor images for evaluation. Another purpose of this study is to learn if a new radio-tracer for tumor imaging called 3'-deoxy-3'(18) F-fluorothymidine (FLT) can improve the evaluation of tumors during a PET/CT scan. This new type of image tracking is meant to improve the visualization of tumor active and size.

Condition Intervention
Esophageal Cancer
Drug: 3'-deoxy-3'-(18) F-fluorothymidine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 3'-Deoxy-3'(18) F-Fluorothymidine Positron Emission Tomography/Computed Tomography (PET/CT) for Initial Staging, Radiotherapy Target Definition, and Assessment of Response to Therapy in Patients With Esophageal Cancer: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.

Other Outcome Measures:
  • Analyze Correlation Between FDG and FLT PET Scans, and the Correlation Between Both Types of PET Scan and the Response to Treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will compare the findings of FDG and FLT PET scans at pre-treatment, mid-treatment and post-treatment time points to determine how closely they correlate with each other, and if there is a specific time point at which any observed differences between FDG and FLT PET scans are most pronounced. We will also determine which of the six PET scans may correlate most closely with the response to treatment as determined by pathologic findings at esophagectomy.

Enrollment: 5
Study Start Date: August 2010
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLT PET
This is a single arm trial, in which all patients receive three FDG-PET scans and three FLT-PET scans, before, during and after pre-operative chemoradiation for esophageal cancer.
Drug: 3'-deoxy-3'-(18) F-fluorothymidine
Radio-tracer for tumor imaging
Other Name: FLT

Detailed Description:
  • The following are standard medical procedures that are part of regular cancer care that the participant would probably have done even if they did not join the study: Chemotherapy; physical examination; pregnancy test (if applicable); diagnostic FDG-PET/CT scan before and after treatment to evaluate disease.
  • The following diagnostic procedures are being done specifically because of this study: Three FLT-PET/CT scans before, during and after treatment and one FDG PET/CT scan during treatment.
  • Participants will be in this research study for approximately 12-14 weeks.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction. Biopsy or cytology of the primary tumor, or of involved regional lymph nodes, is acceptable.
  • Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic ultrasound. T1 tumors are eligible if they are T1, N1, M0. Regional thoracic lymph node involvement is permitted.
  • Disease must be clinically limited to the esophagus or gastroesophageal junction. If the tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction. Adenocarcinomas of the distal esophagus would therefore include tumors of the gastroesophageal junction which involve equally both the distal esophagus and proximal stomach, or Siewert type II. Tumor much be surgically resectable and have a minimum length of 2cm.
  • Patients must be judged by their oncologist to be a candidate for combined modality therapy with chemotherapy consisting of oxaliplatin with protracted infusion 5-FU and concurrent radiation.
  • FDG PET/CT performed off-site must be available for review by the Overall PI in DICOM format and has been performed within one month of study entry
  • 18 years of age or older
  • ECOG Performance Status 0-1
  • Laboratory values as outlined in the protocol

Exclusion Criteria:

  • No prior chemotherapy or radiotherapy is permitted. Patients must be at least 4 weeks since major surgery, or must have recovered from the effects of minor surgery.
  • No prior malignancies (other than basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or superficial transitional cell bladder carcinoma) are permitted unless diagnosed and/or treated 3 years or longer before registration and without evidence of recurrence.
  • Patients with the following tumor characteristics are not eligible: TIS (in situ carcinoma); tumors determined to be T1N0 following endoscopic ultrasound; supraclavicular (for distal tumors) or celiac (for proximal tumors) lymph node involvement, as determined by EUS, CT scan, or PET scan, unless this is proven to be a false positive by an appropriate biopsy; cervical esophageal tumors, or gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus; no patients with tracheoesophageal fistulas
  • Patients with evidence of metastatic disease
  • No poorly controlled diabetes despite attempts to improve glucose control by fasting duration and adjustment of medications
  • Pregnant and breast feeding women are excluded
  • HIV-positive individuals on combination antiretroviral therapy are ineligible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243619

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Harvey J. Mamon, MD, PhD Brigham and Women's Hospital/Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Harvey Mamon, MD, PhD, Radiation Oncologist, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01243619     History of Changes
Other Study ID Numbers: 10-169
Study First Received: September 30, 2010
Results First Received: February 18, 2015
Last Updated: August 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 13, 2015