68Ga-FAPI-46 for Cancer

Overseen By Nicole Jones

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Eben Rosenthal

Disqualifiers: Recent MI, CVA, CHF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Approximately 45 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a new imaging method, 68Ga-FAPI-46 PET/CT, with standard MRI or CT scans in individuals with solid tumors. The goal is to determine if this new imaging can more effectively show tumor response to treatment. Participants will receive an injection of 68Ga-FAPI-46, a radioactive tracer, and undergo a PET/CT scan before continuing their usual cancer treatment. The trial seeks individuals diagnosed with any stage of solid tumor cancer who are about to begin antibody-based therapy. As an Early Phase 1 trial, this research focuses on understanding how the new imaging method functions in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

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 prior data suggests that 68Ga-FAPI-46 is safe for PET/CT imaging in cancer patients?

Research has shown that 68Ga-FAPI-46 is safe for people. Studies indicate that using 68Ga-FAPI-46 for PET/CT scans carries no major risks and provides clear, reliable images. The radiation from 68Ga-FAPI-46 is low, making harm unlikely. Patients and healthy volunteers who received 68Ga-FAPI-46 reported no negative side effects. Overall, evidence suggests this method is safe for imaging cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

68Ga-FAPI-46 is unique because it uses a novel imaging agent, 68Ga-FAPI-46, to enhance cancer detection through PET/CT scans. Unlike traditional imaging methods that may rely on glucose uptake, this treatment targets fibroblast activation protein (FAP), which is prevalent in many tumors, potentially providing clearer and more specific imaging results. Researchers are excited about its ability to offer more precise tumor visualization, which could lead to improved diagnosis and treatment planning for cancer patients.

What evidence suggests that 68Ga-FAPI-46 is effective for imaging solid tumors?

Research has shown that 68Ga-FAPI-46, which participants in this trial will receive, is highly effective for cancer imaging. Studies have found it outperforms traditional methods like 18F-FDG PET due to its greater sensitivity, detecting cancer more accurately (96% compared to 73%). For certain cancers, such as sarcoma, it even detects all cases perfectly. This technique also provides stable and clear images, aiding in accurate tumor identification. These early findings suggest that 68Ga-FAPI-46 could be a promising tool for improved cancer assessment and monitoring. ^{6 7 8 9 10}

Who Is on the Research Team?

Eben Rosenthal, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: 68 Ga FAPI-46 Experimental Treatment 1 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.

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+

Published Research Related to This Trial

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]

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]

In a study of 103 patients using 68Ga-FAPI-04 PET/MR imaging, focal uptake of the tracer was found in the pancreas, indicating that it can occur in benign conditions such as pancreatic pseudocysts and prior pancreatitis, rather than just malignant tumors.

The findings suggest that while 68Ga-FAPI-04 is promising for cancer diagnosis, careful evaluation is necessary to avoid misdiagnosis, and the combination with MR imaging may help differentiate between benign and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. Zhang, X., Song, W., Qin, C., 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 43 cancer patients, 68Ga-FAPI-46 PET imaging showed that the optimal uptake for detecting tumors occurred at just 10 minutes after administration, with only slight declines in uptake at 1 and 3 hours.

The imaging results indicated stable tumor and background uptake over the 3-hour period, suggesting that scans could be performed as early as 10-20 minutes post-injection, which could enhance patient experience by reducing wait times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Time-Point PET Analysis of 68Ga-FAPI-46 in a Variety of Cancers. Naeimi, M., Choyke, PL., Dendl, K., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

68Ga-FAPI-04 is an effective PET imaging agent that can help diagnose conditions like IgG4-related disease (IgG4-RD) by targeting fibroblast activation protein, which is often present in tumors and inflammatory tissues.

In a case study of a 62-year-old patient, 68Ga-FAPI PET provided clearer diagnostic information than traditional 18F-FDG PET, highlighting its potential to differentiate between pancreatitis and pancreatic cancer when other imaging results are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/MR is helpful in differential diagnosis of pancreatitis from pancreatic malignancy compared to 18F-FDG PET/CT: a case report. Shou, Y., Xue, Q., Yuan, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12065268/

a meta-analysis of [68ga] FAPI- 46 vs. [18f] FDG imaging Conclusions. This study revealed that [68Ga] FAPI- 46 outperforms [18F] FDG in cancer diagnosis, with higher sensitivity (0.96 vs. 0.73) and ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.457

68Ga-FAPI-46 PET/CT for cancer imaging: Results of a ... Patient-based PPV/SE for 68Ga-FAPI-46 (18F-FDG) PET were 94/72% (97/71%) for GU cancers, 100/96% (100/96%) for sarcoma, and 100/91% (100/88%) ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/64/4/618

Three-Time-Point PET Analysis of 68Ga-FAPI-46 in a Variety ... 68 Ga-FAPI-46 PET/CT imaging revealed remarkably stable tumor and background uptake as determined by SUV metrics and maintained high TBRs within 3 h of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06911021?cond=pancreatic+cancer

68Ga-FAPI-46 in Staging of Pancreatic Adenocarcinoma This clinical study investigates the use of a new imaging technique called 68Ga-FAPI-46 PET/CT in people with pancreatic ductal adenocarcinoma (PDAC), ...

5. nature.com nature.com/articles/s41598-023-43049-2

Comparison of early and late 68Ga-FAPI-46-PET in 33 ... In addition, a recent study demonstrated that 68Ga-FAPI-PET shows higher sensitivity in detecting primary pancreatic tumors, involved lymph ...

6. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00299-2/fulltext

[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ... The use of [68Ga]Ga-FAPI-46 PET–CT demonstrates no relevant risks while providing consistent and standardisable results, supporting its ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7413240/

Radiation Dosimetry and Biodistribution of 68Ga-FAPI-46 ... The average effective total-body dose was 7.80E−03 mSv/MBq. Conclusion: 68Ga-FAPI-46 PET/CT has a favorable dosimetry profile, with an estimated whole-body dose ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05518903

NCT05518903 | Investigational Scan (68Ga-FAPI-46 PET/ ... This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/64/8/1210

Clinical Evaluation of 68 Ga-FAPI-RGD for Imaging of ... Results: 68Ga-FAPI-RGD was tolerated well, with no adverse events in any of the healthy volunteers or patients. The effective dose from 68Ga- ...

10. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-025-02835-x

a meta-analysis of [68ga] FAPI- 46 vs. [18f] FDG imaging This study revealed that [68Ga] FAPI- 46 outperforms [18F] FDG in cancer diagnosis, with higher sensitivity (0.96 vs. 0.73) and specificity (0.92 vs. 0.83).