FAPi & PSMA PET/CT Imaging for Cancer Detection

Not currently recruiting at 1 trial location

Overseen By Ethan Lam

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Pregnant, Nursing, New cancer therapy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new imaging techniques to improve cancer detection in the body. It examines how well two special tracers, Gallium Ga 68 FAPi-46 and Gallium Ga 68-labeled PSMA-11, appear on PET/CT scans, which combine information about body structure and metabolic activity. The trial aims to determine if these scans accurately reflect the cancer tissue removed during surgery. It seeks patients with specific types of cancer, such as breast, colon, or lung, who are scheduled for surgery. Participants must remain still for up to an hour during the imaging process. As an Early Phase 1 trial, this research focuses on understanding how these imaging techniques function in people, offering participants a chance to contribute to groundbreaking 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. It's best to discuss this with the research team or your doctor.

What prior data suggests that these imaging techniques are safe for cancer detection?

Research has shown that Gallium Ga 68 FAPi-46 is under study for its ability to image cancer-associated fibroblasts, the cells surrounding tumors. Studies indicate it can effectively distinguish between cancerous and non-cancerous tissues. Although specific safety data remains limited, its use in imaging suggests it is well-tolerated in small, controlled doses.

Gallium Ga 68-labeled PSMA-11 is more established and already FDA-approved for imaging prostate cancer. Research has demonstrated its ability to help detect other cancers as well. This approval indicates safety when used as directed.

This trial is in the early stages, focusing on how these imaging agents function in the body. While early trials typically emphasize safety, the existing approval of PSMA-11 is a positive sign for its safety. Participants can expect careful monitoring throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative imaging techniques for cancer detection, using Gallium Ga 68-labeled compounds like FAPi-46 and PSMA-11. Unlike traditional imaging methods that primarily rely on 18F-FDG, these new agents target specific molecules expressed in cancer cells, potentially offering more precise and detailed images of tumors. This could lead to earlier and more accurate detection of various cancers, which is crucial for improving treatment outcomes. Additionally, the optional use of PSMA PET/CT for volunteers adds another layer of specificity, especially for prostate cancer imaging. These advancements in imaging may revolutionize how cancers are diagnosed and monitored, providing a clearer path to personalized treatment strategies.

What evidence suggests that these imaging techniques are effective for cancer detection?

Research has shown that 68Ga-FAPi-46 PET/CT scans, one of the imaging techniques used in this trial, effectively detect cancer-related cells called fibroblasts. These scans are highly sensitive in identifying primary pancreatic tumors and affected lymph nodes. Some studies identified fibroblast activation protein (FAP) in 85-97% of ovarian cancers using this method.

Meanwhile, 68Ga-PSMA-11 PET/CT scans, another imaging technique in this trial, have proven very effective in detecting recurrent prostate cancer and its metastasis. This tracer is not limited to prostate cancer; it has also performed well in identifying other cancer types. Overall, both imaging techniques tested in this trial show promise for detecting cancerous tissues in the body. ^{1 5 6 7 8}

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 patients scheduled for cancer surgery who can consent and comply with study procedures. It's open to those with breast, colon, esophageal, gastric, head and neck, lung, ovarian, pancreatic, renal or uterus cancer. Pregnant/nursing individuals or those whose conditions might affect data quality are excluded.

Inclusion Criteria

I am scheduled for surgery to remove my cancer.

Patient can provide written informed consent

I can stay still for up to an hour for a scan.

Exclusion Criteria

Patient is pregnant or nursing

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

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

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 scan over 20-50 minutes. On another day, they may receive 18F-FDG and undergo PET/CT according to standard of care procedures. Optional 68Ga-PSMA-11 PET/CT for volunteer patients.

1-2 weeks

Multiple visits for imaging procedures

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FDG
• Computed Tomography
• Gallium Ga 68 FAPi-46
• Gallium Ga 68-labeled PSMA-11
• Positron Emission Tomography

Trial Overview The trial studies new PET/CT imaging techniques using tracers like Gallium Ga 68-labeled PSMA-11 and FAPi-46 to see how they accumulate in normal vs. cancer tissues. The goal is to match PET images with actual tumor tissue removed during surgery.

How Is the Trial Designed?

Group I: Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT) Experimental Treatment 5 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). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Society of Nuclear Medecine and Molecular Imaging

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

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 case study of a 65-year-old man with metastatic prostate cancer, 68 Ga-FAPI PET/CT successfully detected a primary tumor that was not visible on 68 Ga-PSMA or 18 F-FDG PET/CT scans, suggesting its potential as a valuable diagnostic tool.

Histopathological examination confirmed the presence of a high-grade Gleason 4 + 5 prostate cancer, indicating that 68 Ga-FAPI PET/CT may improve detection and localization of clinically relevant prostate cancer cases that other imaging methods might miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68 Ga-FAPI PET/CT Detected Non-PSMA/FDG-Avid Primary Tumor in De Novo Metastatic Prostate Cancer. Pang, Y., Meng, T., Xu, W., et al.[2023]

The study highlights the imaging characteristics of a metastatic superscan using gallium-68-PSMA PET/CT, a new radiotracer being tested for prostate cancer imaging.

This imaging technique was used to assess a patient with extensive bone metastases, indicating its potential role in evaluating candidates for targeted therapies like Lu-177-PSMA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic superscan in prostate carcinoma on gallium-68-prostate-specific membrane antigen positron emission tomography/computed tomography scan. Agarwal, KK., Tripathi, M., Kumar, R., et al.[2020]

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]

Total-body PET/CT dynamic scanning in 54 patients revealed distinct biodistribution patterns for the tracers [18F]F-FDG, [68Ga]Ga-PSMA-11, and [68Ga]Ga-FAPI-04, indicating their effective uptake in major organs, which is crucial for understanding their clinical applications.

The mean effective doses calculated for [18F]F-FDG, [68Ga]Ga-PSMA-11, and [68Ga]Ga-FAPI-04 were found to be comparable, with [18F]F-FDG showing a lower effective dose than previously reported, while the other two tracers had higher values, highlighting the importance of total-body PET/CT for accurate dose assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biodistribution and radiation dosimetry of multiple tracers on total-body positron emission tomography/computed tomography. Li, L., Wan, L., Zhao, H., et al.[2023]

F-PSMA-1007 PET/CT imaging effectively identified prostate cancer and multiple bone metastases in a 77-year-old patient, but also revealed a primary liver cancer, highlighting its potential for detecting additional diseases beyond prostate cancer.

The case emphasizes the importance of careful interpretation of PSMA-PET/CT results, as increased tracer uptake in unexpected lesions may indicate other conditions, necessitating further pathological examination for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidental detection of primary hepatocellular carcinoma on 18F-prostate-specific membrane antigen-1007 positron emission tomography/computed tomography imaging in a patient with prostate cancer: A case report. Zhao, H., Li, Y., Hou, S., et al.[2022]

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 comparing Ga-FAPI and F-FDG PET/CT in a patient with cholangiocellular carcinoma, Ga-FAPI PET demonstrated significantly higher tumor-to-background contrast, making it more effective in visualizing the primary tumor.

Ga-FAPI PET was also better at detecting metastatic lesions, particularly micrometastases in bones, compared to F-FDG PET, suggesting its potential for improved cancer staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 68Ga-FAPI and 18F-FDG PET/CT in a Patient With Cholangiocellular Carcinoma: A Case Report. Pang, Y., Hao, B., Shang, Q., et al.[2021]

The novel imaging probe [68Ga]Ga-FAPI-PSMA shows high affinity for prostate cancer cells, making it effective for diagnostic imaging, with IC50 values of 4.73 nM for PSMA and 2.10 nM for FAP expressing cells.

In vivo studies demonstrated that [68Ga]Ga-FAPI-PSMA rapidly accumulates in prostate tumors and provides optimal imaging results at 1 hour post-injection, while also having a relatively low radiation dose compared to other imaging probes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging. Wang, P., Wang, S., Liu, F., et al.[2023]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. Afaq, A., Payne, H., Davda, R., et al.[2022]

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]

In a case study of a 76-year-old man with newly diagnosed prostate cancer, 18F-PSMA-1007 PET/CT showed minimal activity in the primary tumor and metastases, indicating limitations in detecting certain prostate cancer cases.

In contrast, 18F-FAPI-04 PET/CT revealed more active lesions in the primary tumor and metastatic sites, suggesting that it may be a more effective imaging option for prostate cancer patients with low PSMA expression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibroblast Activation Protein-Targeted PET/CT Imaging in a Treatment-Naive Prostate Cancer Patient With Low PSMA Expression. Mu, X., Li, M., Huang, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9553066/

[68Ga]Ga-FAPI-46 PET for noninvasive detection of ... Our results showed that [68Ga]Ga-FAPI-46 PET was able to detect lung injury in a bleomycin pulmonary fibrosis model and detect increased fibrogenesis in a ...

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

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

3. 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 ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12461-w

Diagnostic accuracy and clinical value of [68Ga]Ga-FAPI-46 ... In pathological studies of human cancer tissue, FAP expression has been detected in 85–97% of ovarian cancers, both in serous and mucous ...

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

Comparison of early and late 68Ga-FAPI-46-PET in 33 ... In addition, a recent study demonstrated that 68Ga-FAPI-PET shows higher sensitivity in detecting primary pancreatic tumors, involved lymph ...

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

[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ... Background: The fibroblast activation protein α (FAP)-directed radiotracer [68Ga]Ga-FAPI-46 for PET-CT has shown promising diagnostic accuracy ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04457258

NCT04457258 | 68Ga-FAPi-46 PET/CT Scan in Imaging ... PRIMARY OBJECTIVE: I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer ...

8. 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.