Clinical trial NCT03318497: Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
Official title: Initial Evaluation of Role of Early Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic adenocarcinoma
18F-FLT
FLT
Locally advanced pancreatic adenocarcinoma
Borderline resectable pancreatic adenocarcinoma
resectable pancreatic adenocarcinoma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle.

Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.
Primary purpose: DIAGNOSTIC

Brief summary: To assess if percentage change in 18F-FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of neoadjuvant chemotherapy can predict overall survival at 1 and 2 years and progression free survival at 6 months and 1 year in patients with borderline resectable or locally advanced, pancreatic adenocarcinoma.

Detailed description: The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.

Visit 1: Patients will have at least one visit with investigator (or investigator designee) prior to the study to review clinical history and prior treatment of pancreatic adenocarcinoma, and to explain the study. Correlative radiology studies including CT, MRI and 18F FDG-PET/CT as per institutional routine clinical care, and any clinically-directed laboratory tests performed as part of staging must be performed within 30 days of the 18F FLT-PET/CT

Visit 2 (Optional): The 18F-FDG-PET/CT may be done as a research scan, if the patient is unable to obtain a clinically-directed 18F-FDG-PET/CT as part of their clinical care or within 30 days of 18F FLT-PET/CT. The research 18F-FDG-PET/CT, in this instance, will be identical in procedure to the institution's clinical 18F-FDG-PET/CT. The blood glucose level will be \< 200 mg/dl, before 18F-FDG injection, which is institutional standard clinical protocol. The following additional patient data will be obtained: histological diagnosis of primary and/or metastatic disease, date of diagnosis of primary and metastatic disease, gender, height, weight (for BMI), ECOG score and confirmation of absence of prior treatment.

Visit 3: Day of 18F-FLT-PET/CT: The patient will have an intravenous line placed in the hand or arm, 18F-FLT-PET/CT will be given by 1-2 minute IV push, and the dose administered will be approximately 5 mCi (+/- 20% dose). After approximately 60 +/- 10 minutes of uptake time, the patient will be positioned supine in the PET/CT scanner for standard whole body PET/CT scan from the skull base to mid-thigh. This scan will take approximately 20-30 min. The window from FLT PET/CT baseline study to initiation of chemotherapy should be no more than 30 days.

Visit 4: Day of Interim 18F-FLT-PET/CT: The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle. The second 18F-FLT-PET/CT study must be performed on the same scanner as the first 18F FLT-PET/CT and the imaging protocol described in Visit 3 should be closely followed.

Study duration:

Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.

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Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed pancreatic adenocarcinoma (resectable, borderline resectable or locally advanced disease at presentation) are eligible for the study.
* Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study.
* Patients must be over 18 years old and capable and willing to provide informed consent.
* Patients must have measurable disease (by RECIST 1.1 criteria)
* Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age \>70 years).
* Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to FLT (or FDG if for research) PET/CT imaging per institution's standard of care; A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria; Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
* Medically stable as judged by patient's physician.
* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to FLT are NOT eligible.
* Ability to understand and the willingness to sign a written informed consent.
* Patient must be able to lie still for a 20 to 30 minute PET/CT scan.

Exclusion Criteria:

* Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study.
* Patient must NOT be pregnant or breast-feeding.
* Patients have no clinical evidence of distant metastatic disease
* Patients must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed.(\>200kg or 440lbs)

Primary outcomes:
measure: Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy
timeFrame: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
measure: Change From Baseline in SUV Peak of Lesion After 2 Cycles of Chemotherapy
timeFrame: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
measure: Change From Baseline in Proliferative Tumor Volume After 2 Cycles Chemotherapy
timeFrame: Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)
measure: 1 Year Overall Survival
timeFrame: Baseline(pre-treatment), until date of first observed death, assessed up to 1 year
measure: 2 Year Overall Survival
timeFrame: Baseline(pre-treatment), until date of first observed death, assessed up to 2 years
Secondary outcomes:
measure: 6 Months Progression Free Survival
timeFrame: Baseline (pre-treatment), until date of first observed progression, assessed up to 6 months
measure: 1 Year Progression Free Survival
timeFrame: Baseline(pre-treatment), until date of first observed progression, assessed up to 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Soutwestern Medical Center
name: Daniella Pinho, MD
role: PRINCIPAL_INVESTIGATOR
References: