Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People With Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT05141643|
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : March 16, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreatic Ductal Adenocarcinoma||Diagnostic Test: PET Scan||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients|
|Actual Study Start Date :||November 18, 2021|
|Estimated Primary Completion Date :||November 18, 2024|
|Estimated Study Completion Date :||November 18, 2024|
Experimental: Participants with pancreatic ductal adenocarcinoma (PDAC)
Participants will have histologically-confirmed pancreatic ductal adenocarcinoma (PDAC). The experimental design of this study is to perform a single [18F]-FAC PET scan prior to the administration of chemotherapy with an optional second [18F]-FAC PET scan procedure during SOC treatment to observe changes in tumor uptake and biodistribution. Patients will be offered a second [18F]-FAC PET scan procedure during their SOC treatment. This second scan will be optional.
Diagnostic Test: PET 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.
Other Name: 18F-FAC PET Scan
- Tumor drug uptake within PDAC tumors prior at pre-treatment baseline [ Time Frame: 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
- changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy. [ Time Frame: 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- Women who are pregnant or breast-feeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05141643
|Contact: Heiko Schoder, MDemail@example.com|
|Contact: John Humm, PhDfirstname.lastname@example.org|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Heiko Schoder, MD 646-634-2751|
|Principal Investigator:||Heiko Schoder, MD||Memorial Sloan Kettering Cancer Center|
|Responsible Party:||Memorial Sloan Kettering Cancer Center|
|Other Study ID Numbers:||
|First Posted:||December 2, 2021 Key Record Dates|
|Last Update Posted:||March 16, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: email@example.com.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
pancreatic ductal adenocarcinoma
Memorial Sloan Kettering Cancer Center
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases