68Ga-FAPi-46 PET/CT Imaging for Sarcoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Disqualifiers: Pregnant, Nursing, New cancer therapy, others
No Placebo Group
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.12345
Is 68Ga-FAPi-46 PET/CT imaging safe for humans?
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.23469
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
See 1 more
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
Trial 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 (Imaging Agent)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Diagnostic (68Ga-FAPI-46 PET/CT)Experimental Treatment4 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Head-to-head evaluation of [18F]FDG and [68 Ga]Ga-DOTA-FAPI-04 PET/CT in recurrent soft tissue sarcoma. [2022]Label="PURPOSE">We aimed to evaluate the value of [68 Ga]Ga-DOTA-FAPI-04 PET/CT for the diagnosis of recurrent soft tissue sarcoma (STS), compared with [18F]FDG PET/CT.
Feasibility of acquisitions using total-body PET/CT with a half-dose [68Ga]Ga-FAPI-04 activity in oncology patients. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">[68Ga]Ga-FAPI-04 (gallium-68-labeled fibroblast activation protein inhibitor-04) PET/CT has been widely used in diagnosing malignant tumors. Total-body PET/CT has a long axial field of view and provides higher sensitivity compared to traditional PET/CT. However, whether the reduced injected dose of [68Ga]Ga-FAPI-04 could obtain qualified imaging has not been evaluated.
Fibroblast Activation Protein Inhibitor (FAPI)-PET Imaging in Sarcoma. [2023]Advances in histopathologic and molecular genetic subtyping of sarcoma will potentially allow identification of novel diagnostic and therapeutic targets for specific subtypes, but a "pan-sarcoma" target is needed. This article provides an overview on expression of one potential candidate, fibroblast activation protein alpha in soft tissue and bone sarcoma, and the resulting application of 68Ga-FAPI as novel imaging probes in these rare tumor entities. Current preclinical and clinical data on 68Ga-FAPI-PET/CT in sarcomas are summarized. 68Ga-FAPI-PET-CT potentially offers important complementary information to be used in diagnostic work-up, assessment of therapy response, and prognostication of soft tissue and bone sarcomas.
68Ga-FAPI as a Diagnostic Tool in Sarcoma: Data from the 68Ga-FAPI PET Prospective Observational Trial. [2022]Bone and soft-tissue sarcomas express fibroblast activation protein (FAP) on tumor cells and associated fibroblasts. Therefore, FAP is a promising therapeutic and diagnostic target. Novel radiolabeled FAP inhibitors (e.g., 68Ga-FAPI-46) have shown high tumor uptake on PET in sarcoma patients. Here, we report the endpoints of the 68Ga-FAPI PET prospective observational trial. Methods: Forty-seven patients with bone or soft-tissue sarcomas undergoing clinical 68Ga-FAPI PET were eligible for enrollment into the 68Ga-FAPI PET observational trial. Of these patients, 43 also underwent 18F-FDG PET. The primary study endpoint was the association between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression analyzed with Spearman r correlation. Secondary endpoints were detection rate, positive predictive value (PPV), interreader reproducibility, and change in management. Datasets were interpreted by 2 masked readers. Results: The primary endpoint was met, and the association between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression was significant (Spearman r = 0.43; P = 0.03). By histopathologic validation, PPV was 1.00 (95% CI, 0.87-1.00) on a per-patient and 0.97 (95% CI, 0.84-1.00) on a per-region basis. In cases with histopathologic validation, 27 of 28 (96%) confirmed patients and 32 of 34 (94%) confirmed regions were PET-positive, resulting in an SE of 0.96 (95% CI, 0.82-1.00) on a per-patient and 0.94 (95% CI, 0.80-0.99) on a per-region basis. The detection rate on a per-patient basis in 68Ga-FAPI and 18F-FDG PET was 76.6% and 81.4%, respectively. In 8 (18.6%) patients, 68Ga-FAPI PET resulted in an upstaging compared with 18F-FDG PET. 68Ga-FAPI PET readers showed substantial to almost perfect agreement for the defined regions (Fleiss κ: primary κ = 0.78, local nodal κ = 0.54, distant nodal κ = 0.91, lung κ = 0.86, bone κ = 0.69, and other κ = 0.65). Clinical management changed in 13 (30%) patients after 68Ga-FAPI PET. Conclusion: We confirm an association between tumoral 68Ga-FAPI PET uptake intensity and histopathologic FAP expression in sarcoma patients. Further, with masked readings and independent histopathologic validation, 68Ga-FAPI PET had a high PPV and sensitivity for sarcoma staging.
Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. [2023]Label="PURPOSE">The present study aims at evaluating the preclinical and the clinical performance of [68Ga]Ga-DATA5m.SA.FAPi, which has the advantage to be labeled with gallium-68 at room temperature.
Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. [2022]Label="PURPOSE">Gallium-68-labeled fibroblast activation protein inhibitor (68Ga-FAPI) is an emerging promising tumor tracer. This study aims to evaluate the diagnostic efficiency of 68Ga-FAPI PET in gastrointestinal cancer, and to determine its potential impact on clinical management.
68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. [2023]68Ga-FAPI is a novel PET agent that has been shown to be promising for imaging tumors. Meanwhile, FAPI uptake in nonmalignant diseases has also been reported. Herein, we presented 68Ga-FAPI PET/CT findings of Baastrup disease in a patient with esophageal cancer.
Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging. [2023]Prostate-specific membrane antigen (PSMA) is a prostate cancer target that plays a crucial role in prostate cancer diagnosis and therapy. Herein, a novel dual-targeted imaging probe, [68Ga]Ga-FAPI-PSMA, was prepared by radiolabeling conjugated DOTA-FAPI-PSMA with the short half-life radionuclide gallium-68 (68Ga), which is dedicated to prostate cancer diagnostic imaging. In vitro, [68Ga]Ga-FAPI-PSMA had higher affinity for the PSMA and FAP high-expressing cell lines 22Rv1 and U87 MG with IC50 values of 4.73 and 2.10 nM, respectively, than in the corresponding negative expression cell lines PC3 and A549, and significant differences in cell uptake were also observed. In vivo, [68Ga]Ga-FAPI-PSMA was rapidly cleared from the body, and the estimated radiation dose was relatively low compared with several other FAPI probes. In 22Rv1 and U87 MG tumor xenografts, [68Ga]Ga-FAPI-PSMA rapidly accumulated in tumors after administration, and the best images can be obtained at 1 h postinjection. In conclusion, the dual-targeted probe [68Ga]Ga-FAPI-PSMA was successfully prepared for in vivo prostate cancer PET/CT imaging.
Current Status of Fibroblast Activation Protein Imaging in Gynecologic Malignancy and Breast Cancer. [2023]68Ga-FAPI-PET/computed tomography (CT) is a novel PET/CT radiotracer particularly developed for oncologic imaging. Gynecologic malignancies comprise a broad spectrum of entities and, along with breast cancer, constitute cancers occurring exclusively or primarily, respectively, in women. Thus, a tracer designed not only for one but multiple malignancies has theoretic attractions. Even in comparison with 18F-FDG, the current standard oncologic tracer of nuclear medicine, 68Ga-FAPI, has demonstrated advantages in several tumors. As breast cancer, ovarian cancer, and cervical cancer are among the most common tumor types in women and are often accompanied by high morbidity as well as mortality rates, a reliable staging tool is paramount for optimal therapeutic management.