Trial Outcomes & Findings for Multi-Tracer PET Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients (NCT NCT02245217)

Results Overview

The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as \>25% reduction in SUVmax.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

1 month

Results posted on

2021-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	PET/CT Imaging Arm Positron Emission Tomography (PET)/CT scan to assess treatment efficacy
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Tracer PET Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET/CT Imaging Arm n=9 Participants PET/CT scan to assess treatment efficacy
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as \>25% reduction in SUVmax.

Outcome measures

Outcome measures
Measure	PET/CT Imaging Arm n=7 Participants PET/CT scan to assess treatment efficacy
FDG Therapeutic Responses to 1 Cycle	6 participant responses based on EORTC

PRIMARY outcome

Timeframe: 1 month

Population: Patients who completed both baseline and follow-up imaging. A synthesis failure for FLT occurred on the follow-up imaging for one patient, so that patient was excluded from the FLT analysis.

The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as \>25% reduction in SUVmax.

Outcome measures

Outcome measures
Measure	PET/CT Imaging Arm n=6 Participants PET/CT scan to assess treatment efficacy
FLT Therapeutic Responses to 1 Cycle	1 participant responses based on EORTC

PRIMARY outcome

Timeframe: 1 month

The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a \>30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion

Outcome measures

Outcome measures
Measure	PET/CT Imaging Arm n=7 Participants PET/CT scan to assess treatment efficacy
RECIST 1.1 Therapeutic Responses to 1 Cycle	3 participant responses based on RECIST1.1

Adverse Events

PET/CT Imaging Arm

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

Josiah Hawks

Huntsman Cancer Institute

Phone: 8015850601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place