30 Participants Needed

FAPi & PSMA PET/CT Imaging for Cancer Detection

Recruiting at 1 trial location
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Overseen ByEthan Lam
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.

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.

Is 68Ga-THP PSMA PET/CT safe for use in humans?

68Ga-THP PSMA PET/CT was found to be safe in a study with no serious adverse events reported, and only minor side effects like itching and a rash at the injection site in two patients.12345

How does the FAPi & PSMA PET/CT imaging treatment differ from other treatments for cancer detection?

The FAPi & PSMA PET/CT imaging treatment is unique because it combines two imaging agents, targeting both fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA), which can help detect prostate cancer even when PSMA expression is low. This dual-targeted approach may provide more comprehensive imaging results compared to traditional methods that focus on a single target.14678

What data supports the effectiveness of this treatment for cancer detection?

Research shows that using Gallium Ga 68 FAPi-46 and Gallium Ga 68 PSMA-11 in PET/CT scans can improve the detection of cancerous tumors and their spread compared to traditional methods. These scans have been particularly effective in identifying more cancerous lesions, including small ones, in various types of cancer.29101112

Who Is on the Research Team?

stromal biomarker for prostate cancer ...

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.
See 2 more

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?
1Treatment groups
Experimental Treatment
Group I: Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)Experimental Treatment5 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).

Find a Clinic Near You

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 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.
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 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.
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]
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.
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]

Citations

The added value of [68Ga]Ga-DOTA-FAPI-04 PET/CT in pancreatic cancer: a comparison to [18F]F-FDG. [2023]
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]
Metastatic superscan in prostate carcinoma on gallium-68-prostate-specific membrane antigen positron emission tomography/computed tomography scan. [2020]
Positron emission tomography and computed tomography with [68Ga]Ga-fibroblast activation protein inhibitors improves tumor detection and staging in patients with pancreatic cancer. [2023]
Comparison of 68Ga-FAPI and 18F-FDG PET/CT in a Patient With Cholangiocellular Carcinoma: A Case Report. [2021]
68 Ga-FAPI PET/CT Detected Non-PSMA/FDG-Avid Primary Tumor in De Novo Metastatic Prostate Cancer. [2023]
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. [2022]
Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging. [2023]
68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Fibroblast Activation Protein-Targeted PET/CT Imaging in a Treatment-Naive Prostate Cancer Patient With Low PSMA Expression. [2023]
Biodistribution and radiation dosimetry of multiple tracers on total-body positron emission tomography/computed tomography. [2023]
12.United Statespubmed.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. [2022]
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