Trial Outcomes & Findings for FLT PET/CT for Staging, Target Definition and Assessment of Response to Therapy in Patients With Esophageal Cancer (NCT NCT01243619)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

1 year

Results posted on

2017-05-17

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 milestones

Participant milestones
Measure	All Participants All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=5 Participants All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
Age, Continuous	63.4 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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.

Outcome measures

Outcome measures
Measure	All Participants n=5 Participants All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy. All patients accepted and complied with having three sets of PET scans performed (six total PET scans). The software used in this protocol has allowed quantitative comparison among the PET scans.
Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

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.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Harvey Mamon MD, PhD

Brigham and Women's Hospital / Dana Farber Cancer Institute

Phone: 617-732-8564

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place