18F-FAC PET Scan for Pancreatic Cancer

Overseen By John Humm, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Breast-feeding, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the 18F-FAC PET Scan treatment for pancreatic cancer differ from other treatments?

The 18F-FAC PET Scan is unique because it uses a special imaging technique to detect pancreatic cancer by highlighting cancerous cells with a radioactive tracer, which can help differentiate between cancer and other conditions like chronic pancreatitis. This method is different from traditional treatments as it focuses on improving diagnosis and detection rather than directly treating the cancer itself. ^{1 2 3 4 5}

Research Team

Heiko Schoder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with confirmed pancreatic cancer (PDAC) who can undergo PET/CT scans. They must be in relatively good health, have a life expectancy of at least 3 months, and not be pregnant or breastfeeding. The study requires informed consent and the ability to have measurable disease on imaging scans.

Inclusion Criteria

I am able to care for myself and perform normal activities with minimal assistance.

My pancreatic cancer diagnosis was confirmed through tissue analysis.

You have a solid tumor that can be seen on a CT or MRI scan.

Exclusion Criteria

I am not pregnant or breastfeeding.

You are not able to have a PET/CT scan due to weight limits or feeling very uncomfortable in small spaces.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment PET Scan

Participants undergo a pre-treatment PET scan using the experimental imaging tracer 18F-FAC to assess tumor drug uptake

1 day

1 visit (in-person)

Standard of Care Treatment

Participants receive standard chemotherapy for pancreatic ductal adenocarcinoma (PDAC)

Varies based on SOC protocol

Optional Second PET Scan

Participants may opt for a second 18F-FAC PET scan during SOC treatment to observe changes in tumor uptake and biodistribution

1 day

1 visit (in-person, optional)

Follow-up

Participants are monitored for changes in 18F-FAC drug uptake and distribution during or following SOC chemo- and/or radiation therapy

2 years

Treatment Details

Interventions

• 18F-FAC

Trial Overview The trial is testing if an experimental PET scan using a tracer called 18F-FAC can predict how well standard chemotherapy will work in treating PDAC by measuring its uptake in the tumor before treatment begins.

Participant Groups

Group I: Participants with pancreatic ductal adenocarcinoma (PDAC) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

In a study of 62 patients with pancreatic cancer, 68Ga-FAPI PET imaging demonstrated a significant association with histopathologic fibroblast activation protein (FAP) expression, indicating its potential as a reliable diagnostic tool.

68Ga-FAPI PET showed superior tumor detection rates compared to traditional imaging methods like 18F-FDG PET and contrast-enhanced CT, achieving 100% sensitivity and high positive predictive values, which could lead to better management of pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Fibroblast Activation Protein Inhibitor (68Ga-FAPI) PET for Pancreatic Adenocarcinoma: Data from the 68Ga-FAPI PET Observational Trial. Kessler, L., Hirmas, N., Pabst, KM., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Pancreatic cancer detected by positron emission tomography with 18F-labelled deoxyglucose: method and first results. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Fibroblast Activation Protein Inhibitor (68Ga-FAPI) PET for Pancreatic Adenocarcinoma: Data from the 68Ga-FAPI PET Observational Trial. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[18F] AlF-NOTA-FAPI-04 PET/CT can predict treatment response and survival in patients receiving chemotherapy for inoperable pancreatic ductal adenocarcinoma. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Role and limitations of 18F-FDG positron emission tomography (PET) in the management of patients with pancreatic lesions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

18F-FDG PET/CT feature of pancreatic adenosquamous carcinoma with pathological correlation. [2021]