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

Multi-Tracer Positron Emission Tomography (PET) Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients

Study of multi-tracer PET scans to assess response to gemcitabine in pancreatic cancer

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Device: PET/CT scan to assess treatment efficacy

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

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:

• Patients must have either

  1. histologically/cytologically-confirmed borderline resectable pancreatic cancer and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their standard of care
  2. histologically/cytologically-confirmed locally advanced unresectable pancreatic cancer and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their standard of care.
• Diagnostic quality abdominal imaging (CT or MRI) within the past 45 days.
• Patients must be 18 years or older for inclusion in this research study. There is little experience with the safety of fluorine-18 (18F) fluorothymidine (FLT) in children and therefore this radiopharmaceutical should not be used in patients under the age of 18.
• Patients must be willing to lie flat on their back in the PET/CT scanner for up to 2 hours to allow the imaging data to be obtained.
• Patients must document their willingness to be followed for up to 24 months following enrollment in this imaging trial. By signing informed consent, the patients will document their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database.
• All patients must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
• Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans. The serum pregnancy test must be performed within 48 hours prior to research PET imaging. A negative test will be necessary for such patients to undergo research PET imaging.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Adequate organ function and laboratory parameters as defined laboratory testing.

Exclusion Criteria:

• Any prior systemic or investigational therapy for pancreatic cancer.
• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals (patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion).
• Patients who are pregnant or lactating or who suspect they might be pregnant. - Serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.
• Adult patients who require monitored anesthesia for PET scanning.
• Patients known to be HIV positive. This is due to the potential toxicities of [18F]FLT in HIV positive patients.
• Pre-existing sensory neuropathy greater than grade 1.
• Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer or any other form of cancer from which the patient has been disease-free for 5 years.
• Uncontrolled diabetes or blood glucose greater than 180 mg/dl on the day of the [18F] fluorodeoxyglucose (FDG) PET scan.
• Major surgery within 4 weeks of the start of study treatment, without complete recovery.
• Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social complications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET/CT Imaging arm	Device: PET/CT scan to assess treatment efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FDG Therapeutic Responses to 1 Cycle	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.	1 month
FLT Therapeutic Responses to 1 Cycle	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.	1 month
RECIST 1.1 Therapeutic Responses to 1 Cycle	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	1 month

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2014
• Primary Completion (Actual): March 17, 2016
• Study Completion (Actual): March 17, 2016

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: HCI74163