- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01243619
FLT PET/CT for Staging, Target Definition and Assessment of Response to Therapy in Patients With Esophageal Cancer
April 12, 2017 updated by: Harvey Mamon, MD, PhD, Dana-Farber Cancer Institute
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Radio-tracer for tumor imaging
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Harvey J. Mamon, MD, PhD, Brigham and Women's Hospital/Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
September 30, 2010
First Submitted That Met QC Criteria
November 17, 2010
First Posted (Estimate)
November 18, 2010
Study Record Updates
Last Update Posted (Actual)
May 17, 2017
Last Update Submitted That Met QC Criteria
April 12, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-169
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophageal Cancer
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
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National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States
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AIO-Studien-gGmbHBristol-Myers SquibbCompletedEsophageal Cancer | Gastrooesophageal Cancer | Oesophageal Cancer | GastroEsophageal Cancer | Esophageal Cancers NOS | Oesophageal Cancer Metastatic | Esophageal Cancer Metastatic | Oesophageal Cancer NosGermany
-
University of Wisconsin, MadisonActive, not recruitingResectable Esophageal Cancer | GastroEsophageal CancerUnited States
-
Tianjin Medical University Cancer Institute and...Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical... and other collaboratorsNot yet recruitingStage III Esophageal Cancer | Stage II Esophageal Cancer
-
Tianjin Medical University Cancer Institute and...UnknownStage III Esophageal Cancer | Stage II Esophageal CancerChina
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Cancer Institute and Hospital, Chinese Academy...Tianjin Medical University Cancer Institute and Hospital; Sichuan Cancer Hospital...UnknownEsophageal Neoplasm | Esophageal Cancer TNM Staging Primary Tumor (T) T3 | Esophageal Cancer TNM Staging Primary Tumor (T) T2 | Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | Esophageal Cancer TNM Staging Distal Metastasis (M) M0China
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7 | Malignant Neoplasm of the Cervical Esophagus | Malignant Neoplasm...United States
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Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtCompletedEsophageal Cancer, Stage II | Esophageal Cancer Stage IIINetherlands
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Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownEsophageal Cancer Stage III | Esophageal Cancer Stage IIBChina
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UNICANCERCompleted