68Ga-FAPi-46 PET/CT Imaging for Sarcoma

Overseen By Stephanie Lira

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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to determine where a tracer, called 68Ga-FAPi-46 (Gallium Ga 68 FAPi-46), accumulates in individuals with sarcoma, a type of cancer. The goal is to better locate cancerous tissues using PET/CT scans, which provide detailed body maps indicating potential cancer locations. The study seeks patients planning to undergo surgery or a biopsy for suspected sarcoma or related issues. Participants must be adults capable of remaining still during scans, which can last up to an hour. As an Early Phase 1 trial, this research aims to understand how the new imaging method functions in people, offering participants a chance to contribute to groundbreaking advancements in cancer detection.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this imaging technique is safe for patients with sarcoma?

Research shows that the 68Ga-FAPi-46 tracer effectively detects cancer through imaging. It safely moves through the body after administration in a small dose. Studies indicate that this tracer accumulates in cancer tissue while mostly avoiding other areas.

Various research settings have studied the safety of 68Ga-FAPi-46. In these studies, patients tolerated the tracer well, with no serious side effects reported. This suggests that the tracer is generally safe for imaging.

Since this trial is in an early phase, the treatment has passed basic safety tests in labs and is now being carefully monitored in humans. While this trial focuses on the tracer's effectiveness in imaging cancer, the low risk of side effects makes it a potentially safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging techniques for sarcoma, which often rely on fluorodeoxyglucose (FDG) PET scans, the 68Ga-FAPi-46 PET/CT imaging uses a new active ingredient, Gallium Ga 68 FAPi-46. This compound targets fibroblast activation protein (FAP), which is abundant in many types of cancer, including sarcoma, allowing for potentially more precise and targeted imaging. Researchers are excited because this method could provide clearer images of the tumor's metabolic activity and structure, potentially leading to better diagnosis and treatment planning.

What evidence suggests that this imaging technique is effective for detecting sarcoma?

Research has shown that the imaging technique using Gallium Ga 68 FAPi-46, which participants in this trial will receive, holds promise for detecting certain cancers. It targets a protein in tumors called fibroblast activation protein (FAP). Early studies suggest it can identify primary tumors and cancer spread more effectively than the usual imaging method, 18F-FDG PET/CT. While it may not perform well for some cancers like Ewing sarcoma, it generally excels in other cases. This suggests that Gallium Ga 68 FAPi-46 could be effective in identifying and imaging sarcomas. ^{2 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 over 18 with suspected or confirmed sarcoma who can consent and stay still for imaging. It's not for pregnant/nursing individuals or those with conditions that could affect data quality.

Inclusion Criteria

I can stay still for up to an hour during scans.

I am scheduled for surgery to remove or biopsy a suspected sarcoma.

Patients who can provide written informed consent

Exclusion Criteria

I haven't started new cancer treatments between my two PET/CT scans.

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

Patient is pregnant or nursing

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 imaging over 20-90 minutes. On another day, they receive 18F-FDG and undergo PET/CT imaging according to standard of care procedures.

1 week

2 visits (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

• Gallium Ga 68 FAPi-46

Trial Overview The trial tests a new imaging technique, 68Ga-FAPi-46 PET/CT, to see how well it shows sarcoma in the body compared to standard methods by tracking a tracer absorbed by cancer cells.

How Is the Trial Designed?

Group I: Diagnostic (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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 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-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]

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]

Advances in understanding sarcoma subtypes may lead to new diagnostic and treatment options, but there is a need for a universal target across all sarcomas.

The use of 68Ga-FAPI-PET/CT imaging shows promise in providing valuable information for diagnosing, assessing treatment responses, and predicting outcomes in soft tissue and bone sarcomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibroblast Activation Protein Inhibitor (FAPI)-PET Imaging in Sarcoma. Kessler, L.[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]

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]

In a study of 45 patients with recurrent soft tissue sarcoma, [68 Ga]Ga-DOTA-FAPI-04 PET/CT detected significantly more lesions (275) compared to [18F]FDG PET/CT (186), demonstrating superior sensitivity, specificity, and overall accuracy for diagnosing recurrent lesions.

[68 Ga]Ga-DOTA-FAPI-04 PET/CT showed higher uptake values in specific sarcoma types like liposarcoma and malignant solitary fibrous tumor, making it a promising imaging tool for recurrent surveillance in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-to-head evaluation of [18F]FDG and [68&#160;Ga]Ga-DOTA-FAPI-04 PET/CT in recurrent soft tissue sarcoma. Gu, B., Liu, X., Wang, S., et al.[2022]

In a study involving 47 patients with bone or soft-tissue sarcomas, 68Ga-FAPI PET imaging showed a significant correlation with histopathologic expression of fibroblast activation protein (FAP), indicating its potential as a reliable diagnostic tool.

The 68Ga-FAPI PET demonstrated a high positive predictive value (PPV) of 1.00 and a sensitivity of 96% for detecting sarcomas, leading to changes in clinical management for 30% of patients, highlighting its efficacy in staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI as a Diagnostic Tool in Sarcoma: Data from the 68Ga-FAPI PET Prospective Observational Trial. Kessler, L., Ferdinandus, J., Hirmas, N., et al.[2022]

Citations

1. 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 ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251432

Head-to-Head Comparison of FAPI-PET/CT vs FDG PET/CT in ... FAPI-PET/CT demonstrated higher pooled sensitivity for the detection of primary tumors and metastatic lesions compared to FDG-PET/CT.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39097807/

Initial clinical experience using 68 Ga-FAPI-46 PET/CT for ... Our findings suggest that FAPI PET/CT is not suitable for evaluating GBM and Ewing sarcoma but generally outperforms 18 F-FDG PET/CT in various types of ...

5. withpower.com withpower.com/trial/early-phase-1-sarcoma-8-2020-118bb

68Ga-FAPi-46 PET/CT Imaging for Sarcoma The treatment Gallium Ga 68 FAPi-46 has shown promise in detecting sarcomas by targeting fibroblast activation protein (FAP), which is present in these tumors.

6. 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) ...

7. 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.

8. researchgate.net researchgate.net/publication/362006182_Safety_and_Efficacy_of_Y-FAPI-46_Radioligand_Therapy_in_Patients_with_Advanced_Sarcoma_and_Other_Cancer_Entities

(PDF) Safety and Efficacy of Y-FAPI-46 Radioligand ... Conclusions ⁹⁰Y-FAPI-46-RLT was safe and led to RECIST PR in one case as well as stable disease in about one third of patients with initially ...

9. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.220749

FAPI PET: Fibroblast Activation Protein Inhibitor Use ... Among many FAP-targeted radiopharmaceuticals developed so far, 68Ga-FAPI exhibits rapid tracer accumulation in target lesions and low background ...