50 Participants Needed

68Ga-FAPI-46 for Cancer

NJ
Overseen ByNicole Jones
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Eben Rosenthal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment 68Ga-FAPI-46 for cancer?

Research shows that 68Ga-FAPI, a similar compound, is effective in diagnosing various cancers, including gastrointestinal cancer, by highlighting tumors in imaging tests. This suggests that 68Ga-FAPI-46 could also be effective in identifying cancerous areas, which can help in managing the disease.12345

Is 68Ga-FAPI-46 safe for use in humans?

68Ga-FAPI has been used in various studies for imaging tumors and other conditions, and it has shown promising results in both preclinical and clinical settings. While specific safety data for 68Ga-FAPI-46 is not detailed, the use of similar compounds in humans suggests it is generally considered safe for diagnostic purposes.12346

How does the drug 68Ga-FAPI-46 differ from other cancer treatments?

68Ga-FAPI-46 is unique because it targets the fibroblast activation protein, which is often found in the supportive tissue around tumors. This makes it a promising tool for both diagnosing and potentially treating various cancers, offering a different approach compared to traditional treatments that may not specifically target this protein.14789

What is the purpose of this trial?

This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 participants will receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after received the study drug. Imaging will occur before starting standard antibody-based therapy. Participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.

Research Team

ER

Eben Rosenthal, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Eligibility Criteria

This trial is for adults over 19 with any stage of solid tumor cancer, confirmed by biopsy, who are about to start antibody-based therapy. They must have good kidney function and acceptable lab results.

Inclusion Criteria

My solid tumor cancer diagnosis was confirmed by a biopsy and I am scheduled for antibody therapy.
I am diagnosed with cancer and will be treated with immunotherapy.
I am 19 years old or older.
See 1 more

Exclusion Criteria

I haven't had a heart attack, stroke, severe heart failure, liver disease, or unstable chest pain in the last 6 months.
I am not pregnant or breastfeeding.
I have severe kidney problems or cannot produce urine.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging and Initial Assessment

Participants receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after. A CT/MRI with contrast is performed approximately one week after the study drug infusion and scan.

2 weeks
2 visits (in-person)

Treatment

Participants proceed with standard antibody-based therapy as determined by their primary treatment team.

Approximately 45 days

Follow-up

Participants are monitored through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.

36 months ± 6 months

Treatment Details

Interventions

  • 68Ga-FAPI-46
Trial Overview The study tests a new PET/CT imaging agent called 68Ga-FAPI-46 against standard MRI or CT scans in patients receiving biologic therapy for solid tumors. Participants will be monitored up to 36 months to see how well the new imaging reflects treatment response.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 68 Ga FAPI-46Experimental Treatment1 Intervention
Each participant who meets criteria will receive one dose of 68 Ga FAPI-46 via IV and then receive a whole body PET/CT Scan the same day of infusion. Participants will be asked to have a CT/MRI with contrast approximately one week after the study drug infusion and scan. Researchers will compare PET/CT images using 68Ga-FAPI-46 to compare uptake determined by MRI or CT with contrast as usual Standard of Care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eben Rosenthal

Lead Sponsor

Trials
9
Recruited
200+

Vanderbilt-Ingram Cancer Center

Collaborator

Trials
221
Recruited
64,400+

Vanderbilt University Medical Center

Collaborator

Trials
922
Recruited
939,000+

Findings from Research

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.
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]
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.
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 54 cancer patients, [68Ga]Ga-DOTA.SA.FAPi showed comparable effectiveness to the standard [18F]F-FDG PET/CT scans in detecting various cancers, with both tracers demonstrating similar uptake in most metastatic regions.
[68Ga]Ga-DOTA.SA.FAPi exhibited significantly higher uptake ratios in brain metastases compared to normal brain tissue, suggesting its potential for better visualization of certain cancer types, while also showing a favorable safety profile with no significant adverse effects reported.
Biodistribution, pharmacokinetics, dosimetry of [68Ga]Ga-DOTA.SA.FAPi, and the head-to-head comparison with [18F]F-FDG PET/CT in patients with various cancers.Ballal, S., Yadav, MP., Moon, ES., et al.[2021]

References

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. [2022]
Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. [2023]
Biodistribution, pharmacokinetics, dosimetry of [68Ga]Ga-DOTA.SA.FAPi, and the head-to-head comparison with [18F]F-FDG PET/CT in patients with various cancers. [2021]
68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. [2023]
[68Ga]/[90Y]FAPI-46: Automated production and analytical validation of a theranostic pair. [2022]
Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. [2022]
Fully automated radiosynthesis of [68Ga]Ga-FAPI-46 with cyclotron produced gallium. [2023]
Three-Time-Point PET Analysis of 68Ga-FAPI-46 in a Variety of Cancers. [2023]
68Ga-FAPI-04 PET/MR is helpful in differential diagnosis of pancreatitis from pancreatic malignancy compared to 18F-FDG PET/CT: a case report. [2021]
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