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NCT Number: NCT05141643

Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People With Pancreatic Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Ductal Adenocarcinoma Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET scan

Diagnostic Test

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 names: 18F-FAC PET Scan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2021
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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