Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Pancreatic Cancer, pancreatic ductal adenocarcinoma, 18F-FAC, Memorial Sloan Kettering Cancer Center, 21-442
Brief summary
The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.
Interventions
DIAGNOSTIC_TESTPET Scan
Participants will receive a minimum of 4 mCi (148 MBq) and up to a maximum of 10 mCi (370 MBq) of \[18F\]-FAC intravenously. Injection is performed in conjunction with a dynamic PET acquisition over a site of the disease (pre-selected based on the findings from a previous CT or MRI and FDG PET/CT study done for clinical purpose such as staging). Patients will be offered a second \[18F\]-FAC PET scan procedure during their SOC treatment. This second scan will be optional.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically-confirmed (confirmed at MSKCC) PDAC * Patients must be ≥ 18 years old * Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF). * Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1. * Karnofsky Performance Status ≥70%. * Life expectancy ≥3 months. * A negative serum pregnancy test, within 1 week of the procedure, if the patient is female of reproductive potential.
Exclusion criteria
* Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia). * Women who are pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor drug uptake within PDAC tumors prior at pre-treatment baseline | Baseline | The primary objective of this study is to obtain preliminary data of tumor drug uptake profile, concentration and distribution within PDAC tumors prior at pre-treatment baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy. | 2 years | To investigate changes in \[18F\]-FAC drug uptake and distribution during or following SOC chemo- and/or radiation therapy. Based on those patients who agree to undergo the second optional \[18F\]-FAC PET scan |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeiko Schoder, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed