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CompletedNCT01243619Updated May 17, 2017Results posted

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

An interventional study of 3'-deoxy-3'-(18) F-fluorothymidine in Esophageal Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Esophageal Cancer

Keywords

  • PET
  • CT
  • radiotherapy
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 5 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 123 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • 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

Interventions

  • Drug3'-deoxy-3'-(18) F-fluorothymidine

    Radio-tracer for tumor imaging

    Also known as: FLT

06

What researchers measure

Primary outcomes

  1. Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis

    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.

    Time frame: 1 year

Other outcomes

  1. Analyze Correlation Between FDG and FLT PET Scans, and the Correlation Between Both Types of PET Scan and the Response to Treatment.

    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.

    Time frame: 1 year

07

Results

Posted Mar 5, 2015

Participant flow

Single arm open label pilot study. Study was expected to enroll five patients at Dana Farber Cancer Institute and Brigham and Women's Hospital. The study was initiated in August 2010 and the primary completion date was March 2013.

Participant flow — Overall Study
MilestoneAll Participants
Started5
Completed5
Not completed0

Outcome measures

PrimaryFeasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis

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.

Time frame:
1 year
Reported as:
Number · participants
Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis
participantsAll Participants
Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis5
Other pre-specifiedAnalyze Correlation Between FDG and FLT PET Scans, and the Correlation Between Both Types of PET Scan and the Response to Treatment.

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.

Time frame:
1 year

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Participants—0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Participants
Mean63.4 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female0
Male5
08

Study locations

3 sites
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01243619
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
Responsible party
Harvey Mamon, MD, PhD (Radiation Oncologist, Dana-Farber Cancer Institute) — Principal investigator
First posted
Nov 18, 2010
Start date
Aug 2010
Primary completion
Mar 2013
Completion
Mar 2013
Results posted
Mar 5, 2015
Last update
May 17, 2017

Study contacts

Harvey J. Mamon, MD, PhD
principal investigator · Dana-Farber/Brigham and Women's Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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