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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique called 68Ga-FAPi-46 PET/CT. The goal is to determine how effectively this tool detects cancer cells and surrounding tissue uptake of the FAPI tracer, potentially aiding in understanding various cancer types. Patients with certain cancers, such as brain, bladder, or skin cancer, who are scheduled for surgery or a biopsy, might be suitable candidates. Participants will receive the tracer through an IV and undergo a PET/CT scan to gather information about their cancer. As a Phase 1 trial, the research focuses on understanding how this new imaging technique functions in people, offering participants the chance to be among the first to benefit from this innovative approach.

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 prior data suggests that this imaging technique is safe for cancer patients?

Research has shown that the imaging technique using 68Ga-FAPi-46 is safe for humans. Studies have found that patients tolerate this tracer well. In one study, the radiation dose from 68Ga-FAPi-46 in the organs of cancer patients remained within safe limits, confirming its safety for imaging use. Another study demonstrated that 68Ga-FAPi-46 can effectively distinguish between cancerous and non-cancerous tissues, making it potentially very useful. Overall, the evidence supports the safety of 68Ga-FAPi-46 for people, with no serious side effects reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FAPi PET/CT imaging technique because it uses a special active ingredient called Gallium Ga 68 FAPi-46. Unlike other imaging methods that often rely on 18F-FDG, this new technique targets a protein called fibroblast activation protein (FAP) found in many cancer cells, offering potentially clearer images. This could help doctors better identify and understand tumors, leading to more precise and personalized treatment plans.

What evidence suggests that this imaging technique is effective for cancer?

In this trial, participants will undergo imaging with 68Ga-FAPi-46 PET/CT, which research has shown is highly effective at identifying cancer-related fibroblasts. These cells surround and support tumors. One study found that this imaging method correctly identified fibroblast activity in tumors 90% of the time, making it very reliable in showing where these cells are active in the body. It is especially helpful for cancers with strong tissue reactions, such as breast, colon, and pancreatic cancers. These findings suggest that 68Ga-FAPi-46 PET/CT could be a powerful tool in cancer imaging. ^{1 6 7 8 9}

Who Is on the Research Team?

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

My cancer type is listed among the specified types for the trial.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

[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 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 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 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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12325145/

Preclinical evaluation of [68Ga]Ga-AAZTA-FAPI-46 Results. Gallium-68 radiolabelling was achieved with high radiochemical yield at room temperature. The new tracer was stable in different media, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05518903

Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of ... This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts ...

3. nature.com nature.com/articles/s41598-023-43049-2

Comparison of early and late 68Ga-FAPI-46-PET in 33 ... Early and late acquisition of 68 Ga-FAPI-PET results in comparable imaging information in patients with possible recurrence of PDAC.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40774265/

[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ... The patient-based PPV of [68Ga]Ga-FAPI-46 PET for detecting FAP-positive tumours based on immunohistochemical FAP staining was 90% (95% CI 84-95) ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220749

FAPI PET: Fibroblast Activation Protein Inhibitor Use in ... Ga-FAPI PET is especially useful for tumors with a strong desmoplastic reaction, such as breast, colon, and pancreatic cancers, as well as ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/64/8/1232

Tumor Characterization by [ 68 Ga]FAPI-46 PET/CT Can ... We conclude that [ 68 Ga]FAPI-46 PET/CT can accurately differentiate malignant from benign pancreatic lesions deemed equivocal by standard-of-care imaging.

7. ejnmmipharmchem.springeropen.com ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-025-00375-2

Preclinical evaluation of [68Ga]Ga-AAZTA-FAPI-46: a ... The aim of this work was to demonstrate the suitability of AAZTA chelator conjugated to a FAPI-46-derived FAP inhibitor and labelled with ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04457258

NCT04457258 | 68Ga-FAPi-46 PET/CT Scan in Imaging ... This early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7413240/

Radiation Dosimetry and Biodistribution of 68Ga-FAPI-46 ... Herein we describe the biodistribution of 68Ga-FAPI-46 and its estimated radiation dose deposition in the organs of 6 cancer patients who underwent 68Ga-FAPI-46 ...