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

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT02245217
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Device: PET/CT scan to assess treatment efficacy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Multi-Tracer Positron Emission Tomography (PET) Prediction and Assessment of Response to Gemcitabine in Pancreatic Cancer Patients
• Actual Study Start Date: Dec 12, 2014
• Actual Primary Completion Date: Mar 17, 2016
• Actual Study Completion Date: Mar 17, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. FDG Therapeutic Responses to 1 Cycle [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.

2. FLT Therapeutic Responses to 1 Cycle [1 month]

   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.

3. RECIST 1.1 Therapeutic Responses to 1 Cycle [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT02245217
• Other Study ID Numbers: HCI74163
• First Posted: Sep 19, 2014
• Last Update Posted: Oct 15, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	PET/CT Imaging Arm
Arm/Group Description	Positron Emission Tomography (PET)/CT scan to assess treatment efficacy
Period Title: Overall Study
STARTED	9
COMPLETED	7
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	PET/CT Imaging Arm
Arm/Group Description	PET/CT scan to assess treatment efficacy
Overall Participants	9
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	67
Sex: Female, Male (Count of Participants)
Female	4 44.4%
Male	5 55.6%

Outcome Measures

1. Primary Outcome

Title	FDG Therapeutic Responses to 1 Cycle
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PET/CT Imaging Arm
Arm/Group Description	PET/CT scan to assess treatment efficacy
Measure Participants	7
Number [participant responses based on EORTC]	6

2. Primary Outcome

Title	FLT Therapeutic Responses to 1 Cycle
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PET/CT Imaging Arm
Arm/Group Description	PET/CT scan to assess treatment efficacy
Measure Participants	6
Number [participant responses based on EORTC]	1

3. Primary Outcome

Title	RECIST 1.1 Therapeutic Responses to 1 Cycle
Description	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
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PET/CT Imaging Arm
Arm/Group Description	PET/CT scan to assess treatment efficacy
Measure Participants	7
Number [participant responses based on RECIST1.1]	3

Adverse Events

Arm/Group Title	PET/CT Imaging Arm
Arm/Group Description	PET/CT scan to assess treatment efficacy
All Cause Mortality
	PET/CT Imaging Arm
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PET/CT Imaging Arm
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	PET/CT Imaging Arm
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.