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Clinical Trial · NCT03318497
Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
Overview
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.
Sponsor
University of Texas Southwestern Medical Center
Phase
Phase 2
Contacts
Daniella Pinho, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03318497Drug / Compound
FDG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
fluorothymidine
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- cytosolic thymidine kinase 1
Ligand Class: Small Molecules
Eligibility
Inclusion
- Patient must be able to lie still for a 20 to 30 minute PET/CT scan.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to FLT are NOT eligible.
- Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study.
- Patients with histologically confirmed pancreatic adenocarcinoma (resectable, borderline resectable or locally advanced disease at presentation) are eligible for the study.
- Patients must have measurable disease (by RECIST 1.1 criteria)
Exclusion
- Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study.
- Patients have no clinical evidence of distant metastatic disease
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