68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer

NCT05160051 | Completed Phase 2

• 1 other identifier: FAPI-PET Trial
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to explore the safety and tolerability as well as diagnostic accuracy of 68Ga-FAPI-46 for different FAP-expressing tumor entities by PET. This study does not offer any treatment for patients with FAP-expressing carcinomas; therefore, patients will be offered state of the art therapeutic options. Routine surgery will be performed within 8 weeks after 68Ga-FAPI-46 PET.

Conditions

Tumor, Solid

Keywords

radiotracer; PET scan; FAPI-46; 68Ga-radiotracer

Outcome Measures

Primary Outcomes (1)

• Positive predictive value (PPV) on a per-region- and per-patient-basis (table 3) of 68Ga-FAPI46 PET for detection of histopathology-FAP-positive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%).

  within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP

Secondary Outcomes (7)

• Correlation between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression

  within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP

• Sensitivity and specificity of FAPI-PET on a per-patient and per-region-basis for detection of histopathology-FAP-positive tumor lesions confirmed by histopathology/biopsy

  within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP

• Detection rate of FAPI-PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level

  up to time point when patient reaches end-of-study criterion (30day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy)

• Sensitivity and specificity of FAPI-PET vs. previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histo/biopsy/FU imaging/clinical FU reference standard

  up to time point when patient reaches end-of-study criterion (30 day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy)

• Inter-reader reproducibility: determination of FAPI-PET scan interpretation reliability by three independent evaluators

  through study completion, an average of 1 year

Study Arms (1)

68Ga-FAPI-46 PET Scan

EXPERIMENTAL

A single-center prospective interventional single-arm clinical trial. All eligible subjects undergo FAPI-PET Scan

Diagnostic Test: 68Ga-FAPI-46 PET Scan

Interventions

68Ga-FAPI-46 PET Scan DIAGNOSTIC_TEST

68Ga-FAPI-46 is a radiotracer that binds with high affinity to Fibroblast Activating Protein (FAP). FAP is physiologically expressed in many tissues during embryonic development, but in adults it is expressed only in the context of wound healing, fibrotic processes, and the stroma of many malignancies. Therefore, the study seeks to validate if 68Ga-FAPI-46 PET could be established as a diagnositc tool to detect solid tumors.

68Ga-FAPI-46 PET Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven or suspected tumor types: Breast, Colorectal, Endometrial, Esophageal, Glioma/GMB, Head and neck, Hepatocellular carcinoma, ,Lymphoma, Multiple Myeloma, Neuroendocrine, NSCLC (Non small cell lung cancer), Ovarian, Pancreatic, Prostate, Renal cell carcinoma, Sarcoma, SCLC (Small cell lung cancer), Semimoma, Thyroid, Unknown primary, Other
• At initial staging or re-staging of disease
• At least one detectable tumor lesion with any diameter \>1 cm
• Intended or performed surgery or biopsy of tumor within 8 weeks before or after enrollment
• Age ≥18 years
• Patient Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Women of child bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, can only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test within 24 h before radiopharmaceutical application.

You may not qualify if:

• Patient cannot give consent for the study
• Patient cannot lie flat or tolerate 68Ga-FAPI-46 PET imaging
• Prior external beam radiation therapy (EBRT) within 3 months of enrollment to tumor lesions intended for surgery or biopsy
• Prior chemotherapy, immunotherapy, biologic or targeted oncologic therapy within 3 months of enrollment
• Unwillingness or inability to comply with study and follow-up procedures
• History of disease or condition that may critically interfere with participation in this study at the discretion of the investigators
• Pregnant, lactating, or breast-feeding women
• Women of child bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study, unless they are using highly effective methods of contraception during the interventional period. Highly effective contraception methods include:
• True sexual abstinence: defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception.
• Vasectomised partner is a highly effective birth control method if the partner is the sole sexual partner of the study participant and the vasectomised partner has received medical assessment of the surgical success.
• Bilateral tubal occlusion.
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
• oral
• intravaginal
• transdermal

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

Department of Nuclear medicine, University hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (3)

• Pabst KM, Weber MM, Laschinsky C, Sandach P, Bartel T, Kuper AT, Kessler L, Trajkovic-Arsic M, Eckstein M, Gilman E, Nader M, Barbato F, Podleska LE, Hadaschik BA, Hamacher R, Kersting D, von Ostau N, von Tresckow B, Kaelberlah HP, Kesch C, Kuemmel S, Reinacher-Schick A, Schuler M, Siveke JT, Grunwald V, Herrmann K, Fendler WP. [68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with histopathology validation: a single-centre, single-arm, interventional, phase 2 trial. Lancet Oncol. 2025 Sep;26(9):1204-1214. doi: 10.1016/S1470-2045(25)00299-2. Epub 2025 Aug 4.

  PMID: 40774265 DERIVED

• Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Kersting D, Siveke JT, Herrmann K, Weber M. Head-to-head comparison of 68 Ga-FAPI-46 PET/CT, 18F-FDG PET/CT, and contrast-enhanced CT for the detection of various tumors. Ann Nucl Med. 2025 Mar;39(3):255-265. doi: 10.1007/s12149-024-01993-7. Epub 2024 Oct 23.

  PMID: 39443386 DERIVED

• Hirmas N, Hamacher R, Sraieb M, Kessler L, Pabst KM, Barbato F, Lanzafame H, Kasper S, Nader M, Kesch C, von Tresckow B, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various Malignancies. J Nucl Med. 2024 Mar 1;65(3):372-378. doi: 10.2967/jnumed.123.266652. Epub 2024 Feb 8.

  PMID: 38331453 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single application of 68Ga-68-FAPI-46 PET/CT imaging to detect tumour tissue in patients with newly diagnosed or recurrent cancer

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: December 16, 2021
• Study Start: December 1, 2021
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)