[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

Trial Summary

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 data supports the effectiveness of the treatment [18F]FAPI-74 for cancer detection?

The research shows that [18F]FAPI-74 PET imaging detects cancerous lesions more effectively than the commonly used [18F]FDG PET, with higher uptake in primary and metastatic cancer lesions. This suggests that [18F]FAPI-74 could be a promising tool for diagnosing and staging various cancers. ^{1 2 3 4 5}

How does [18F]FAPI-74 PET imaging differ from other cancer detection methods?

[18F]FAPI-74 PET imaging is unique because it uses a fibroblast activation protein inhibitor, which provides higher image resolution and better detection rates for cancerous lesions compared to the standard [18F]FDG PET imaging. This method is particularly effective for precise staging and characterization of tumors before treatment, offering a promising new approach for cancer detection. ^{2 5 6 7 8}

What is the purpose of this trial?

Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in certain cancer cells. \[18F\]FAPI-74 is a new tracer-a substance that is injected into a person s body before an imaging scan. Researchers believe that \[18F\]FAPI-74 may be able to highlight FAP enzymes more effectively than approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body. Objective: To see if \[18F\]FAPI-74 PET scans are as good or better than other methods for detecting certain cancers. Eligibility: People aged 18 years or older with cancer in 1 of these places: the ducts of the pancreas, liver, gallbladder, or small intestine; stomach; bladder; ovaries; or adrenal glands. They must be enrolled in an NIH treatment study for their cancer. Design: Participants will have 2 baseline scans: 1 with \[18F\]FAPI-74; 1 with an approved tracer. The \[18F\]FAPI-74 will be infused through a tube attached to a needle inserted into a vein. About 1 hour later, the participant will undergo 1 or more imaging scans. Within 1 week, participants will undergo the same scanning procedures with the approved tracer. If the baseline scan with \[18F\]FAPI-74 shows the tumors, scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scans with the regular tracer also showed tumors, this scan will be repeated within the same week as the repeated \[18F\]FAPI-74 scans. If either type of scan showed no tumors, that scan will not be repeated. If the participant s cancer progresses within 2 years, both types of scan may be repeated. Follow-up calls will continue for 2 years.

Research Team

Esther Mena Gonzalez, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

References

1. Switzerland 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. [2022]

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

Initial Evaluation of [18F]FAPI-74 PET for Various Histopathologically Confirmed Cancers and Benign Lesions. [2023]

3. Japan 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. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

What radiolabeled FAPI pet can add in breast cancer? A systematic review from literature. [2023]

5. Germany 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

FAPI PET/CT in Diagnostic and Treatment Management of Colorectal Cancer: Review of Current Research Status. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Physiological tracer distribution and benign lesion incidental uptake of Al18F-NOTA-FAPI-04 on PET/CT imaging. [2023]

8. Germany 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. [2022]