FAPi PET/CT Imaging for Cancer

(FAPI PET RDRC Trial)

Overseen By Ethan Lam

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Pregnancy, New cancer therapy, 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?

This trial tests a new scan to help see where cancer is in patients. The scan highlights cancer cells, which could help doctors find and understand cancer better.

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, it does exclude patients who have started new cancer therapy between the baseline and investigational PET/CT scans.

What data supports the effectiveness of the treatment FAPi PET/CT Imaging for Cancer?

Research shows that 68Ga-FAPI PET/CT imaging is effective in detecting and staging various cancers, including pancreatic and non-small cell lung cancer, by providing clear images of tumors with high tracer uptake and low background noise, making it more effective than traditional methods like 18F-FDG PET/CT. ^{1 2 3 4 5}

Is FAPi PET/CT Imaging safe for humans?

FAPi PET/CT Imaging, using gallium-68, has been used in various studies for imaging tumors and other conditions, showing promising results with reduced radiation exposure compared to older methods. While specific safety data for FAPi PET/CT is limited, the reduced radiation dose suggests it may be safer than traditional imaging techniques. ^{6 7 8 9 10}

How is FAPi PET/CT imaging different from other cancer imaging treatments?

FAPi PET/CT imaging uses a novel tracer called 68Ga-FAPI, which targets fibroblast activation protein, making it potentially more effective in detecting various cancers compared to the standard 18F-FDG PET/CT. This imaging method can provide clearer images with a lower dose of the tracer, offering a more sensitive and specific option for diagnosing and staging cancers. ^{1 5 7 8 11}

Research Team

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with various cancers, including brain, bladder, testicular, skin, thyroid, liver cancer and more. Participants must be able to stay still for imaging procedures up to an hour and are scheduled for surgery or biopsy of the tumor. Pregnant or nursing individuals or those starting new cancer therapies before the study's PET/CT scans cannot join.

Inclusion Criteria

I am scheduled for surgery to remove or biopsy my cancer.

I can stay still for up to an hour.

I am 18 years old or older.

Exclusion Criteria

Patient is pregnant or nursing

Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data

I haven't started any new cancer treatments between my initial and follow-up PET/CT scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive 68Ga-FAPi-46 intravenously and undergo PET/CT over 20-90 minutes

1 day

1 visit (in-person)

Comparative Imaging

Participants receive 18F-FDG and undergo PET/CT according to standard of care procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

Up to 2 years

Treatment Details

Interventions

• Computed Tomography
• Gallium Ga 68 FAPi-46
• Positron Emission Tomography

Trial Overview The study tests a new imaging technique using 68Ga-FAPi-46 PET/CT to see how well it shows where FAPI tracer accumulates in both normal and cancer tissues. This could help understand different cancers better by visualizing a protein associated with tumor-surrounding cells.

Participant Groups

Group I: Basic science (68GA-FAPI-46 PET/CT) Experimental Treatment 4 Interventions

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Findings from Research

[68Ga]Ga-FAPI-04 PET/CT has a sensitivity for detecting primary liver tumors that is comparable to contrast-enhanced CT and liver MRI, making it a reliable diagnostic tool for liver cancer.

This imaging technique outperforms [18F]-FDG PET/CT in identifying liver lesions, suggesting it could enhance tumor staging and treatment planning for patients with liver cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT. Guo, W., Pang, Y., Yao, L., et al.[2021]

In a study of 51 pancreatic cancer patients, [68Ga]Ga-DOTA-FAPI-04 PET/CT demonstrated superior sensitivity compared to [18F]FDG PET/CT for detecting primary tumors (100% vs. 95%), metastatic lymph nodes (96.2% vs. 61.5%), and distant metastases (100% vs. 84%), indicating it may be a more effective diagnostic tool.

The study found that a SUVmax greater than 14.9 on [68Ga]Ga-DOTA-FAPI-04 PET/CT was significantly associated with better progression-free survival rates, suggesting it could serve as an independent prognostic factor for patients with pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The added value of [68Ga]Ga-DOTA-FAPI-04 PET/CT in pancreatic cancer: a comparison to [18F]F-FDG. Liu, Q., Shi, S., Liu, S., et al.[2023]

In a study of 36 patients with suspected pancreatic malignancies, [68Ga]Ga-FAPI PET/CT demonstrated significantly higher sensitivity and radiotracer uptake compared to [18F]FDG PET/CT for detecting primary tumors, lymph node involvement, and metastases.

[68Ga]Ga-FAPI PET/CT also improved TNM staging in 26.1% of cases compared to [18F]FDG, indicating its potential to enhance clinical management decisions in pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography and computed tomography with [68Ga]Ga-fibroblast activation protein inhibitors improves tumor detection and staging in patients with pancreatic cancer. Pang, Y., Zhao, L., Shang, Q., et al.[2023]

In a study of 28 patients with newly diagnosed non-small cell lung cancer (NSCLC), 68Ga-FAPI PET/CT demonstrated superior detection of metastases compared to 18F-FDG PET/CT, particularly in lymph nodes, pleura, liver, and bone.

68Ga-FAPI PET/CT also showed better semi-quantitative parameters, such as target-to-background ratio (TBR) and maximum standard uptake value (SUVmax), leading to improved staging accuracy for NSCLC patients, with 80% accuracy for N staging and 92.9% for M staging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 68Ga-FAPI and 18F-FDG PET/CT in the Evaluation of Patients With Newly Diagnosed Non-Small Cell Lung Cancer. Wu, J., Deng, H., Zhong, H., et al.[2022]

In a study of 75 cancer patients, [68Ga]Ga-DOTA-FAPI-04 PET/CT demonstrated a significantly higher detection rate for primary tumors (98.2%) compared to [18F] FDG PET/CT (82.1%), indicating its superior diagnostic capability.

[68Ga]Ga-DOTA-FAPI-04 PET/CT also outperformed [18F] FDG PET/CT in detecting lymph node involvement and metastases, with sensitivity rates of 86.4% versus 45.5% for lymph nodes and 83.8% versus 59.5% for bone and visceral metastases, highlighting its effectiveness in identifying metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [68Ga]Ga-DOTA-FAPI-04 and [18F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. Chen, H., Pang, Y., Wu, J., et al.[2021]

In a study involving 60 patients, Ga-68 citrate PET-CT showed lower sensitivity (69%) and specificity (67%) for detecting bone and joint infections compared to Ga-67 citrate scintigraphy, which had a sensitivity of 81% and specificity of 79%.

Reporting physicians expressed significantly lower confidence in the results from Ga-68 citrate PET-CT, primarily due to confusing blood pool activity near infection sites, leading to the conclusion that Ga-68 citrate PET-CT is not recommended to replace Ga-67 citrate scintigraphy in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between gallium-68 citrate positron emission tomography-computed tomography and gallium-67 citrate scintigraphy for infection imaging. Segard, T., Morandeau, LMJA., Dunne, ML., et al.[2020]

68Ga-FAPI is a new PET imaging agent that shows promise for detecting tumors, indicating its potential utility in cancer diagnosis.

The study highlights the use of 68Ga-FAPI PET/CT imaging in a patient with Baastrup disease and esophageal cancer, suggesting that FAPI uptake may also be relevant in nonmalignant conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. Yang, X., Liu, Y., Chen, J., et al.[2023]

Using half-dose [68Ga]Ga-FAPI-04 in total-body PET/CT imaging allows for a reduced acquisition time of 120 seconds while still achieving a 100% tumor detection rate in 27 patients, indicating its efficacy in diagnosing malignant tumors.

The image quality remains acceptable at this reduced dose and time, making it a safer option for radiation-sensitive populations, such as children and pregnant women, who may require shorter imaging sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of acquisitions using total-body PET/CT with a half-dose [68Ga]Ga-FAPI-04 activity in oncology patients. Chen, Z., Wang, Y., Yang, X., et al.[2023]

The radiotracer [68Ga]Ga-DATA5m.SA.FAPi can be prepared easily at room temperature and shows high stability and affinity for FAP, making it a promising tool for imaging in cancer diagnostics.

In clinical trials with six prostate cancer patients, [68Ga]Ga-DATA5m.SA.FAPi demonstrated rapid and stable tumor uptake, supporting its potential as an effective diagnostic tool for FAP imaging in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. Escudero-Castellanos, A., Kurth, J., Imlimthan, S., et al.[2023]

In a study involving 120 patients with gastrointestinal cancers, 68Ga-FAPI PET demonstrated a diagnostic accuracy of 95.0%, significantly outperforming conventional imaging and 18F-FDG PET, which had accuracies of 65.1% and 69.0%, respectively.

68Ga-FAPI PET not only provided more accurate staging but also revised treatment plans for 22.9% of patients compared to conventional imaging, highlighting its potential to significantly impact clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Qin, C., Song, Y., Gai, Y., et al.[2022]

68Ga-FAPI-PET/CT is a new imaging tool designed for detecting various gynecologic cancers, showing potential advantages over the standard 18F-FDG tracer in identifying tumors.

This novel tracer could improve the staging and management of common female cancers like breast, ovarian, and cervical cancer, which are associated with high morbidity and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Fibroblast Activation Protein Imaging in Gynecologic Malignancy and Breast Cancer. Dendl, K., Koerber, SA., Watabe, T., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

The added value of [68Ga]Ga-DOTA-FAPI-04 PET/CT in pancreatic cancer: a comparison to [18F]F-FDG. [2023]

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

Positron emission tomography and computed tomography with [68Ga]Ga-fibroblast activation protein inhibitors improves tumor detection and staging in patients with pancreatic cancer. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of 68Ga-FAPI and 18F-FDG PET/CT in the Evaluation of Patients With Newly Diagnosed Non-Small Cell Lung Cancer. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Comparison of [68Ga]Ga-DOTA-FAPI-04 and [18F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Comparison between gallium-68 citrate positron emission tomography-computed tomography and gallium-67 citrate scintigraphy for infection imaging. [2020]

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

68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of acquisitions using total-body PET/CT with a half-dose [68Ga]Ga-FAPI-04 activity in oncology patients. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. [2022]

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

Current Status of Fibroblast Activation Protein Imaging in Gynecologic Malignancy and Breast Cancer. [2023]