[18F]FAPI-74 PET Imaging for Cancer Detection

Overseen By Yolanda L McKinney, R.N.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Allergies, Claustrophobia, Pregnancy, Renal failure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method using [18F]FAPI-74, a radioactive tracer, to determine if it can detect certain cancers more effectively than current techniques. By injecting this tracer before a scan, researchers aim to enhance tumor visibility, especially those linked to a specific enzyme associated with some cancers. Suitable candidates for this trial include individuals diagnosed with specific cancers, such as pancreatic, liver, or ovarian cancer, who are planning to receive treatment. Participants will undergo imaging sessions with both the new and an existing tracer to compare results. The goal is to improve cancer detection and treatment planning. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer detection.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must be enrolled in another NIH treatment study, it's likely that you can continue your existing treatment.

What prior data suggests that [18F]FAPI-74 PET imaging is safe for cancer detection?

Research shows that [18F]FAPI-74 PET imaging is generally safe. Early studies suggest that this tracer, which aids in cancer detection, does not cause major side effects. Although more detailed safety information from larger studies is needed, the progression of [18F]FAPI-74 to Phase 2 trials indicates that earlier research did not find serious safety issues.

In early tests, [18F]FAPI-74 proved more precise than traditional tracers, with no major side effects reported. This suggests it is less likely to affect blood sugar or physical activity levels. While more data is being collected, initial results are promising for the safety of [18F]FAPI-74. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]FAPI-74 for cancer detection because it offers a new way to see tumors more clearly compared to standard imaging techniques like FDG PET scans. Unlike traditional methods that primarily highlight areas of high glucose metabolism, [18F]FAPI-74 targets fibroblast activation protein (FAP) found in cancer-associated fibroblasts, which are common in many tumors. This unique targeting could potentially lead to more accurate imaging of certain cancers, helping doctors to better diagnose and monitor the disease.

What evidence suggests that [18F]FAPI-74 PET imaging is effective for cancer detection?

Research has shown that a new type of scan, \[18F\]FAPI-74 PET imaging, which participants in this trial will receive, can detect cancer more effectively than the commonly used \[18F\]-FDG PET scans. In studies, \[18F\]FAPI-74 highlighted both original and metastatic cancer areas more clearly, making cancer spots light up more distinctly during scans. It demonstrated a high accuracy rate of 96%, comparable to other advanced imaging methods like MRI. This precision allows \[18F\]FAPI-74 to potentially identify and display tumors more accurately, aiding doctors in better visualizing the cancer. This capability makes it a promising tool for detecting certain types of cancers. ^{2 4 5 6 7}

Who Is on the Research Team?

Esther Mena Gonzalez, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for adults with certain cancers (pancreatic, stomach, liver, bladder, ovarian, bile duct cancer or pheochromocytoma) who are already enrolled in an NIH treatment study. They must be willing to undergo PET scans using a new tracer and an approved tracer.

Inclusion Criteria

I agree to use effective birth control during and for 2 months after the study.

My cancer can be measured or assessed by tests.

Participants must be co-enrolled in an NIH parent cancer treatment clinical trial with planned evaluation of response per RECIST v.1.1 and other imaging considered standard of care (SOC)

Exclusion Criteria

History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes

Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal

Weight > 350 lbs., or inability to fit within the imaging gantry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline [18F]FAPI-74 PET and 18F-FDG PET imaging

1 week

2 visits (in-person)

Follow-up Imaging

Participants with positive baseline scans undergo additional imaging at the time of re-staging or if cancer progression is suspected

Up to 2 years

As needed based on treatment schedule

Follow-up

Participants are monitored for progression-free survival and overall survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FAPI-74

Trial Overview [18F]FAPI-74 is a new imaging agent being tested against the standard [18F]FDG for its ability to detect tumors in various cancers. Participants will receive two baseline scans with each tracer and may have repeat scans based on tumor visibility and progression.

How Is the Trial Designed?

Group I: 1/Arm 1 Experimental Treatment 2 Interventions

\[18F\]FAPI-74 and 18F-FDG PET imaging

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 31 patients with various confirmed cancers, [18F]FAPI-74 PET demonstrated significantly higher uptake in primary cancer lesions compared to nonmalignant lesions, indicating its potential for better cancer detection.

[18F]FAPI-74 PET outperformed [18F]FDG PET in detecting primary and metastatic lesions, suggesting it could be a more effective diagnostic tool for cancer staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [18F]FAPI-74 PET for Various Histopathologically Confirmed Cancers and Benign Lesions. Watabe, T., Naka, S., Tatsumi, M., et al.[2023]

In a study of 20 female patients with breast cancer, 68Ga-FAPI-04 PET/CT demonstrated superior sensitivity (100%) and specificity (95.6%) for detecting primary breast tumors compared to 18F-FDG PET/CT, which had a sensitivity of 78.2% and specificity of 100%.

FAPI PET/CT also outperformed FDG PET/CT in identifying metastases in lymph nodes, liver, bone, and brain, showing significantly higher SUVmax values and tumor-to-background ratios, indicating its effectiveness in detecting smaller lesions and providing clearer imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/CT, a new step in breast cancer imaging: a comparative pilot study with the 18F-FDG PET/CT. Kömek, H., Can, C., Güzel, Y., et al.[2021]

FAPI PET/CT is an innovative imaging technique that effectively targets fibroblast activation protein (FAP), resulting in high tumor visibility and a favorable tumor-to-background ratio, which is crucial for accurate cancer staging and detection.

This imaging method shows promise in enhancing the management of colorectal cancer by potentially improving staging, monitoring for recurrence, and guiding treatment decisions, ultimately aiming to improve patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FAPI PET/CT in Diagnostic and Treatment Management of Colorectal Cancer: Review of Current Research Status. Cheng, Z., Wang, S., Xu, S., et al.[2023]

The study analyzed 20 cancer patients undergoing 18F-FAPI PET/CT imaging, establishing normal uptake ranges for 18F-FAPI in various organs, including the urinary tract, pancreas, and thyroid, while noting no uptake in the brain and lungs.

Incidental uptake of 18F-FAPI in benign lesions was observed in conditions like thyroiditis and arthritis, which may affect the specificity of 18F-FAPI PET/CT imaging in cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological tracer distribution and benign lesion incidental uptake of Al18F-NOTA-FAPI-04 on PET/CT imaging. Kou, Y., Jiang, X., Yao, Y., et al.[2023]

In a study of 38 patients with gastric cancer, [68Ga]Ga-FAPI-04 PET demonstrated a 100% sensitivity for detecting primary gastric cancer, significantly outperforming [18F]-FDG PET, which had an 82% sensitivity.

[68Ga]Ga-FAPI-04 PET also showed higher standardized uptake values (SUVmax) in larger and more advanced tumors, indicating its potential for better diagnosis and staging of gastric cancer compared to [18F]-FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [68 Ga]Ga-FAPI-04 and [18F]-FDG for the detection of primary and metastatic lesions in patients with gastric cancer: a bicentric retrospective study. Jiang, D., Chen, X., You, Z., et al.[2022]

In a study involving 24 cancer patients, multiple timepoint FAPI-PET imaging revealed distinct uptake patterns for malignant, inflammatory, and degenerative lesions, enhancing diagnostic accuracy.

The study found that pancreatic carcinoma showed stable or increasing uptake over time, while inflammatory lesions exhibited a marked decrease, indicating that time-dependent behavior can help differentiate between types of lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subclass Analysis of Malignant, Inflammatory and Degenerative Pathologies Based on Multiple Timepoint FAPI-PET Acquisitions Using FAPI-02, FAPI-46 and FAPI-74. Glatting, FM., Hoppner, J., Kauczor, HU., et al.[2022]

In a study of 71 cancer patients comparing 68Ga-FAPI and 18F-FDG PET/CT imaging, 68Ga-FAPI showed comparable tumor uptake while demonstrating significantly lower background uptake in normal organs, which can enhance diagnostic clarity.

The higher tumor-to-background ratios (TBR) for 68Ga-FAPI, particularly in liver and bone metastases, suggest that it may provide better diagnostic information in cancers where 18F-FDG has high physiological uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-to-head intra-individual comparison of biodistribution and tumor uptake of 68Ga-FAPI and 18F-FDG PET/CT in cancer patients. Giesel, FL., Kratochwil, C., Schlittenhardt, J., et al.[2022]

FAPI PET imaging in breast cancer patients showed promising results, detecting more lesions and providing higher tumor-to-background ratios compared to the standard 2-[18F]FDG imaging, based on a review of 13 studies involving 172 patients.

Despite these advantages, the overall quality of the studies was low, and no significant differences in FAPI uptake were found based on the cancer's histopathological characteristics, indicating the need for further prospective trials to confirm its clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What radiolabeled FAPI pet can add in breast cancer? A systematic review from literature. Evangelista, L., Filippi, L., Schillaci, O.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10394310/

Initial Evaluation of [18F]FAPI-74 PET for Various ... 18 F FAPI-74 PET showed significantly higher uptake in primary and metastatic lesions of various histopathologically confirmed cancers than did 18 F FDG PET.

2. trials.braintumor.org trials.braintumor.org/trials/NCT06503146

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET ... Researchers believe that [18F]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make ...

3. nature.com nature.com/articles/s44303-024-00053-z

Clinical applications of fibroblast activation protein inhibitor ... FAPI-PET sensitivity (96%) has also been favorably compared to other modalities such as MRI (100%) or contrast-enhanced CT for detection of HCC ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05641896

NCT05641896 | Study of [18F]FAPI-74 PET in Patients With ... The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06149

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ... Researchers believe that [18F]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT06503146

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8897030/

Preclinical evaluation and pilot clinical study of [18F]AlF ... [18F]AlF-P-FAPI, as a FAP tracer for PET imaging, has a higher specificity compared to [18F]FDG and is independent of blood-sugar and physical activity.