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

Primary Purpose

Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

PET Scan

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, pancreatic ductal adenocarcinoma, 18F-FAC, Memorial Sloan Kettering Cancer Center, 21-442

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with pancreatic ductal adenocarcinoma (PDAC)

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor drug uptake within PDAC tumors prior at pre-treatment 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 Outcome Measures

changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy.

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

Full Information

NCT ID

NCT05141643

First Posted

November 19, 2021

Last Updated

August 2, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05141643

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 18, 2021 (Actual)

Primary Completion Date

November 18, 2025 (Anticipated)

Study Completion Date

November 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Cancer, pancreatic ductal adenocarcinoma, 18F-FAC, Memorial Sloan Kettering Cancer Center, 21-442

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Participants with pancreatic ductal adenocarcinoma (PDAC)

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

PET Scan

Other Intervention Name(s)

18F-FAC PET Scan

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tumor drug uptake within PDAC tumors prior at pre-treatment baseline

Description

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

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy.

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heiko Schoder, MD

Phone

646-634-2751

schoderh@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

John Humm, PhD

Phone

212-639-7367

hummj@mskcc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

646-634-2751

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

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

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