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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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) accumulates in normal and cancer tissues in patients with sarcoma. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi. Because some cancers take up 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.

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 data supports the effectiveness of the treatment Gallium Ga 68 FAPi-46 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. In a study, it demonstrated a high positive predictive value and sensitivity for staging sarcomas, and it changed clinical management in 30% of patients, indicating its potential effectiveness in diagnosing and assessing sarcoma. ^{1 2 3 4 5}

Is 68Ga-FAPi-46 PET/CT imaging safe for humans?

Research on similar compounds like [68Ga]Ga-FAPI-PSMA shows that it is rapidly cleared from the body and has a relatively low radiation dose, suggesting it is generally safe for human use. ^{2 5 6 7 8}

How does 68Ga-FAPi-46 PET/CT imaging differ from other sarcoma treatments?

68Ga-FAPi-46 PET/CT imaging is unique because it targets fibroblast activation protein (FAP), which is expressed in sarcoma cells, allowing for precise imaging and potentially better staging compared to traditional methods like 18F-FDG PET. This novel approach can change clinical management by providing more accurate information about the tumor's presence and spread. ^{2 3 4 6 9}

Research Team

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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

Head-to-head evaluation of [18F]FDG and [68&#160;Ga]Ga-DOTA-FAPI-04 PET/CT in recurrent soft tissue sarcoma. [2022]

2. 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]

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

Fibroblast Activation Protein Inhibitor (FAPI)-PET Imaging in Sarcoma. [2023]

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

68Ga-FAPI as a Diagnostic Tool in Sarcoma: Data from the 68Ga-FAPI PET Prospective Observational Trial. [2022]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

8. United States 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. [2023]

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

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