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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new type of PET scan can predict how well standard chemotherapy will be absorbed by pancreatic cancer. The scan uses an experimental tracer called 18F-FAC to provide a clearer picture of the cancer before treatment. Individuals with pancreatic ductal adenocarcinoma, confirmed by tests and able to safely undergo a PET scan, are suitable candidates. Participation involves at least one scan before starting chemotherapy, with an option for another scan during treatment to observe any changes. As an Early Phase 1 trial, this research focuses on understanding how the new PET scan functions in people, offering participants a chance to contribute to groundbreaking advancements in cancer diagnostics.

Will I have to stop taking my current medications?

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

What prior data suggests that this imaging tracer is safe for use in PET scans?

Research has shown that the 18F-FAC tracer remains in the early testing stages for PET scan use. Limited safety information is currently available. In this early phase study, researchers aim to assess how well participants tolerate the tracer. The primary goal is to determine its safety and its potential to produce useful images of pancreatic cancer.

By joining this trial, participants contribute to scientists' understanding of the 18F-FAC tracer's safety. Although specific information on side effects or negative reactions is not yet available, the trial focuses on exploring these aspects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-FAC PET scan for pancreatic cancer because it offers a new way to visualize how pancreatic ductal adenocarcinoma (PDAC) responds to treatment. Unlike traditional imaging methods, which may not capture changes at the molecular level, 18F-FAC PET scans can detect metabolic changes in tumors before and during standard chemotherapy. This could lead to more personalized treatment plans, potentially improving outcomes by allowing doctors to adjust therapies based on real-time insights into how the cancer is reacting.

What evidence suggests that this PET scan is effective for pancreatic cancer?

Research has shown that 18F-FAC is a new imaging tool tested in this trial to evaluate its effectiveness in tracking chemotherapy in pancreatic cancer. Although limited information exists about 18F-FAC in humans, similar tools like 18F-FAPI and 18F-FDG have shown promise in detecting cancer. Studies have demonstrated that these tools can accurately identify both the primary cancer and any metastasis. This suggests that 18F-FAC might also provide important imaging details for treating pancreatic cancer. Early results indicate it could help doctors assess how much chemotherapy reaches the cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Heiko Schoder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858376/

18F-FAPI-04 Outperforms 18F-FDG PET/CT in Clinical ... Our results demonstrate that 18F-FAPI-04 PET/CT is significantly superior to 18F-FDG PET/CT in detecting both primary and metastatic lesions.

2. nature.com nature.com/articles/s41598-024-77022-4

The value of PET/CT radiomics for predicting survival ... Despite advancements in surgical techniques, radiation, and chemotherapy, the 5-year survival rate for PDAC remains remarkably low, typically ...

3. link.springer.com link.springer.com/article/10.1007/s11307-024-01950-w

Prospective Comparison of [ 18 F]FDG and [ 18 F]AIF-FAPI ... Our results showed that [18F]AIF-FAPI-74 PET/CT was superior to [18F]FDG PET/CT in detecting primary tumors and metastatic lymph nodes in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05884463?term=AREA%5BBasicSearch%5D(FDG)&rank=2

18F-FAPI PET Imaging in Pancreatic Adenocarcinoma To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F- FDG PET/CT. Detailed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8799156/

The clinical application of 18F-FDG PET/CT in pancreatic ... The study found that the sensitivity, specificity, and diagnostic accuracy of PET/CT for pancreatic cancer were 89% (95% CI: 85–93%), 70% (95% CI: 54–84%), and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07217717?rank=9

Using 18F-FAPI PET to Detect Metastatic Disease in ... The participants will be followed-up for safety for 24 to 72 hours after the dose of [¹⁸F]FAPI-74 PET/CT. Official Title. A Phase 3, Multicenter ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/65/2/206

18F-FAPI-04 Outperforms 18F-FDG PET/CT in Clinical ... 18 F-FAPI-04 PET/CT performed better than 18 F-FDG PET/CT in identification of primary tumors, LN metastasis, and DM and in TNM staging of PDAC.

8. sciencedirect.com sciencedirect.com/science/article/pii/S235204772400008X

Imaging of pancreatic ductal adenocarcinoma – An update ... PET-CT has an estimated 90% sensitivity in detecting pancreatic cancer, but it does not offer clear benefits over CT or MRI for this purpose [19]. Finally, ...

9. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-023-00985-4

18F-FDG-PET/CT-based deep learning model for fully ... A total of 370 PDAC patients from January 2016 to September 2021 were collected retrospectively. All patients underwent 18F-FDG-PET/CT ...