68Ga-FF58 Imaging for Advanced Cancer

Recruiting at 3 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anticoagulants, Antiplatelet agents

Disqualifiers: Bleeding disorder, Pregnancy, Liver dysfunction, others

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

Compensation: Varies

Number of Visits: 1

14 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who need ongoing treatment with blood thinners or antiplatelet drugs. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug [68Ga]-FF58 for advanced cancer?

The research shows that gallium-68 (68Ga) is widely used in diagnostic imaging for cancer, as it can be attached to different molecules to help detect specific cancer markers. This suggests that [68Ga]-FF58 might be effective in imaging advanced cancer by targeting specific cancer-related proteins. ^{1 2 3 4 5}

Is 68Ga-FF58 safe for use in humans?

The safety of 68Ga-labeled radiopharmaceuticals, like [68Ga]Ga-FAPI-RGD, has been evaluated in clinical studies with cancer patients, showing favorable results. In a study with 6 cancer patients, [68Ga]Ga-FAPI-RGD demonstrated good stability and no significant adverse effects, suggesting it is generally safe for human use. ^{5 6 7 8 9}

How does the drug 68Ga-FF58 differ from other treatments for advanced cancer?

68Ga-FF58 is unique because it uses gallium-68, a radiometal, for high-resolution imaging in PET scans, which can target specific biomarkers on tumors. This approach may offer more precise imaging compared to traditional methods, potentially improving the assessment of cancer spread and aiding in personalized treatment planning. ^{5 6 7 10 11}

What is the purpose of this trial?

This trial tests a new imaging agent in adults with advanced cancers. The agent helps make cancer cells visible.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with certain relapsed or refractory solid tumors like glioblastoma, brain-metastasized breast cancer, gastroesophageal adenocarcinoma, or pancreatic cancer. Participants must have confirmed disease progression after treatment and meet specific health criteria such as adequate kidney function and no severe liver issues.

Inclusion Criteria

My GBM has worsened after radiation and I haven't had bevacizumab.

Signed informed consent must be obtained prior to participation in the study

My cancer is in the stomach, esophagus, or where they meet and is advanced.

Exclusion Criteria

My kidney function, measured by creatinine clearance, is less than 40 mL/min.

I am not pregnant, and if breastfeeding, I can stop for 12 hours after treatment. I agree to abstain from sex for 12 hours post-treatment.

I haven't had radiopharmaceuticals within the time frame of 10 half-lives before getting [68Ga]-FF58.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Imaging Characterization

Participants receive a single dose of [68Ga]-FF58 and undergo PET imaging to evaluate imaging performance, safety, biodistribution, and dosimetry

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• [68Ga]-FF58

Trial Overview [68Ga]-FF58 is being tested in this first-in-human study to evaluate its imaging capabilities, safety profile, distribution within the body, and radiation dosage when used in patients with specific types of advanced cancers expected to overexpress αvβ3 and αvβ5 integrins.

Participant Groups

Group I: Pancreatic ductal adenocarcinoma Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) \[but not more than 250 and not less than 150 MBq\]

Group II: Glioblastoma Multiforme Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].

Group III: Gastroesophageal adenocarcinoma Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) \[but not more than 250 and not less than 150 MBq\]

Group IV: Brain Metastasis from Breast Cancer Experimental Treatment 1 Intervention

All eligible participants will receive recommended dose of \[68Ga\]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

In a study of 20 female patients with breast cancer, 68Ga-FAPI-04 PET/CT demonstrated superior sensitivity (100%) and specificity (95.6%) for detecting primary breast tumors compared to 18F-FDG PET/CT, which had a sensitivity of 78.2% and specificity of 100%.

FAPI PET/CT also outperformed FDG PET/CT in identifying metastases in lymph nodes, liver, bone, and brain, showing significantly higher SUVmax values and tumor-to-background ratios, indicating its effectiveness in detecting smaller lesions and providing clearer imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/CT, a new step in breast cancer imaging: a comparative pilot study with the 18F-FDG PET/CT. Kömek, H., Can, C., Güzel, Y., et al.[2021]

Gallium-68 (68Ga) radiopharmaceuticals are emerging as effective alternatives to traditional 99mTc agents for high-resolution imaging in PET scans, with applications in evaluating organ function and targeting specific tumor biomarkers.

The review emphasizes the importance of standardized production and quality control methods for 68Ga radiopharmaceuticals, which are crucial for their safe and effective clinical use, given their favorable properties like short half-life and ease of radiolabeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good practices for 68Ga radiopharmaceutical production. Nelson, BJB., Andersson, JD., Wuest, F., 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 of 38 patients with gastric cancer, [68Ga]Ga-FAPI-04 PET demonstrated a 100% sensitivity for detecting primary gastric cancer, significantly outperforming [18F]-FDG PET, which had an 82% sensitivity.

[68Ga]Ga-FAPI-04 PET also showed higher standardized uptake values (SUVmax) in larger and more advanced tumors, indicating its potential for better diagnosis and staging of gastric cancer compared to [18F]-FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [68&#160;Ga]Ga-FAPI-04 and [18F]-FDG for the detection of primary and metastatic lesions in patients with gastric cancer: a bicentric retrospective study. Jiang, D., Chen, X., You, Z., et al.[2022]

References

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

Repeatability of [68Ga]DKFZ11-PSMA PET Scans for Detecting Prostate-specific Membrane Antigen-positive Prostate Cancer. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Comparison of [68Ga]Ga-PSMA-11 PET/CT with [18F]NaF PET/CT in the evaluation of bone metastases in metastatic prostate cancer patients prior to radionuclide therapy. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/CT, a new step in breast cancer imaging: a comparative pilot study with the 18F-FDG PET/CT. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Diagnostic Efficacy of 68Ga-Labeled Prostate-Specific Membrane Antigen and 18F-Labeled Sodium Fluoride PET/CT in Prostate Cancer With Bone Metastasis]. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Good practices for 68Ga radiopharmaceutical production. [2022]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Comparison of [68&#160;Ga]Ga-FAPI-04 and [18F]-FDG for the detection of primary and metastatic lesions in patients with gastric cancer: a bicentric retrospective study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Novel bifunctional DATA chelator for quick access to site-directed PET 68Ga-radiotracers: preclinical proof-of-principle with [Tyr3]octreotide. [2018]

9. Australia pubmed.ncbi.nlm.nih.gov

Synthesis, preclinical evaluation and radiation dosimetry of a dual targeting PET tracer [68Ga]Ga-FAPI-RGD. [2022]

10. England pubmed.ncbi.nlm.nih.gov

PET imaging of a 68Ga labeled modified HER2 affibody in breast cancers: from xenografts to patients. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-FAPI PET for the evaluation of digestive system tumors: systematic review and meta-analysis. [2023]