Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509549-11-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to investigate the use of the tracer [68Ga]Ga-FAPI-46 for PET/CT-imaging in response evaluation of patients with advanced stage malignant melanoma treated with immune checkpoint inhibitor therapy (ICT). The main question it aims to answer is:
• Can [68Ga]Ga-FAPI-46 PET/CT improve response evaluation in patients suffering from advanced stage malignant melanoma treated with ICT and potentially serve as a biomarker.
Researchers will compare findings on the experimental [68Ga]Ga-FAPI-46 PET/CT with findings on standard imaging ([18F]FDG PET/CT).
Participants will undergo:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced staged Malignant Melanoma | Experimental | Patients with advanced stage malignant melanoma with visible lesions on [18F]FDG PET/CT referred for ICT at the Dept. of Oncology Herlev Hospital will be sought enrolled. Patients will undergo two [68Ga]Ga-FAPI-46 PET/CT, which include injection with the experimental tracer [68Ga]Ga-FAPI-46. These scans are in addition to their standard imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-FAPI-46 | Drug | Patients undergo two PET/CTs with the experimental tracer [68Ga]Ga-FAPI-46 (drug). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT | Specified malignant lesions will be defined and evaluated by a team of specialists on the baseline [68Ga]Ga- FAPI PET/CT scan and the uptake of the FAPI tracer in the lesions will be quantified. The evaluation of the malignant lesions on [68Ga]Ga-FAPI PET/CT will also be compared with a similar lesion evaluation on the [18F]FDG PET/CT (standard imaging). The FAPI-uptake will be reassessed after 12 weeks of ICT by the same team of specialists. Changes in uptake of malignant lesions after 12 weeks of ICT on the [68Ga]Ga-FAPI-46 PET/CT will be compared to changes on the [18F]FDG PET/CT and the clinical response. The clinical response will be assessed using the patients' medical record. | From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in [68Ga]Ga-FAPI-46-uptake during ICT in healthy tissue | Tracer-uptake in healthy tissue and benign lesions on [68Ga]Ga-FAPI-46 PET/CT will be evaluated using the same method as described in "Primary Objectives". A similar evaluation of standard [18F]FDG PET/CT will be performed. FAPI-uptake in healthy tissue on [68Ga]Ga-FAPI-46 PET/CT will be compared to the findings on [18F]FDG PET/CT. To verify the [68Ga]Ga-FAPI-46 PET/CT assessment (including evaluation of healthy tissue, malignant lesions and benign lesions), the assessment will be compared to the findings from a composed reference standard. This consist of all available imaging, biopsy results, blood tests, and information on hospitalization and changes in patient management up to 6 months after the [68Ga]Ga-FAPI PET/CT. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP-activity biomarkers in serum blood samples during ICT. | Blood samples from the included participants will be analyzed by Nordic Bioscience- Results from this analysis will be correlated to the disease activity evaluated on the [68Ga]Ga-FAPI-46 PET/CT. Results from the serum blood sample analysis will also be correlated with treatment outcome after 6 months of treatment. Treatment outcome will be defined using the RECIST criteria (40). This analysis will be done retrospectively on routine clinical scans ([18F]FDGPET/CT). The updated guideline and definitions of the RECIST criteria will be used. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Universityhospital | Recruiting | Herlev | Capital Region | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30257879 | Background | Zhang HE, Hamson EJ, Koczorowska MM, Tholen S, Chowdhury S, Bailey CG, Lay AJ, Twigg SM, Lee Q, Roediger B, Biniossek ML, O'Rourke MB, McCaughan GW, Keane FM, Schilling O, Gorrell MD. Identification of Novel Natural Substrates of Fibroblast Activation Protein-alpha by Differential Degradomics and Proteomics. Mol Cell Proteomics. 2019 Jan;18(1):65-85. doi: 10.1074/mcp.RA118.001046. Epub 2018 Sep 26. | |
| 33620560 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2025 | Sep 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2025 | Sep 22, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
The baseline and the follow-up [68Ga]Ga-FAPI-46 PET/CT scan will be evaluated by a team of experienced specialists in clinical physiology and nuclear medicine, and radiology. These specialists are blinded from findings on the standard imaging ([18F]FDG PET/CT).
Not provided
| From enrollment in the study (signed informed consent) to the end of the follow-up (6 months after the second [68Ga]Ga-FAPI-46 PET/CT, estimated time in total is 9 months from signed informed consent). |
| From enrollment in the study (signed informed consent) to the end of the follow-up (6 months after the second [68Ga]Ga-FAPI-46 PET/CT, estimated time in total is 9 months from signed informed consent). |
| Rigshospitalet | Recruiting | Copenhagen | Ca | 2100 | Denmark |
|
| Background |
| Ferdinandus J, Kessler L, Hirmas N, Trajkovic-Arsic M, Hamacher R, Umutlu L, Nader M, Zarrad F, Weber M, Fendler WP. Equivalent tumor detection for early and late FAPI-46 PET acquisition. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3221-3227. doi: 10.1007/s00259-021-05266-7. Epub 2021 Feb 23. |
| 36581374 | Background | Hirmas N, Hamacher R, Sraieb M, Ingenwerth M, Kessler L, Pabst KM, Barbato F, Lueckerath K, Kasper S, Nader M, Schildhaus HU, Kesch C, von Tresckow B, Hanoun C, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Niedergethmann M, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Fibroblast-Activation Protein PET and Histopathology in a Single-Center Database of 324 Patients and 21 Tumor Entities. J Nucl Med. 2023 May;64(5):711-716. doi: 10.2967/jnumed.122.264689. Epub 2022 Dec 29. |
| 31836685 | Background | Meyer C, Dahlbom M, Lindner T, Vauclin S, Mona C, Slavik R, Czernin J, Haberkorn U, Calais J. Radiation Dosimetry and Biodistribution of 68Ga-FAPI-46 PET Imaging in Cancer Patients. J Nucl Med. 2020 Aug;61(8):1171-1177. doi: 10.2967/jnumed.119.236786. Epub 2019 Dec 13. |
| 33718446 | Background | Finke D, Heckmann MB, Herpel E, Katus HA, Haberkorn U, Leuschner F, Lehmann LH. Early Detection of Checkpoint Inhibitor-Associated Myocarditis Using 68Ga-FAPI PET/CT. Front Cardiovasc Med. 2021 Feb 25;8:614997. doi: 10.3389/fcvm.2021.614997. eCollection 2021. |
| 33914106 | Background | Hotta M, Sonni I, Benz MR, Gafita A, Bahri S, Shuch BM, Yu R, Liu ST, Czernin J, Calais J. 68Ga-FAPI-46 and 18F-FDG PET/CT in a patient with immune-related thyroiditis induced by immune checkpoint inhibitors. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3736-3737. doi: 10.1007/s00259-021-05373-5. Epub 2021 Apr 29. No abstract available. |
| 35155199 | Background | Rong X, Lv J, Liu Y, Wang Z, Zeng D, Li Y, Li S, Wu J, Shen Z, Shi M, Liao W, Wu Z, Wang C. PET/CT Imaging of Activated Cancer-Associated Fibroblasts Predict Response to PD-1 Blockade in Gastric Cancer Patients. Front Oncol. 2022 Jan 26;11:802257. doi: 10.3389/fonc.2021.802257. eCollection 2021. |
| 31428105 | Background | Monteran L, Erez N. The Dark Side of Fibroblasts: Cancer-Associated Fibroblasts as Mediators of Immunosuppression in the Tumor Microenvironment. Front Immunol. 2019 Aug 2;10:1835. doi: 10.3389/fimmu.2019.01835. eCollection 2019. |
| 35137262 | Background | Mokoala K, Emil N, Lawal I, Antke C, Giesel FL, Sathekge M. [68 Ga]Ga-FAPI versus [18F]F-FDG in malignant melanoma: complementary or counterpoint? Eur J Nucl Med Mol Imaging. 2022 Jun;49(7):2445-2446. doi: 10.1007/s00259-022-05702-2. Epub 2022 Feb 9. No abstract available. |
| 26185533 | Background | Zhou L, Yang K, Andl T, Wickett RR, Zhang Y. Perspective of Targeting Cancer-Associated Fibroblasts in Melanoma. J Cancer. 2015 Jun 23;6(8):717-26. doi: 10.7150/jca.10865. eCollection 2015. |
| 30734283 | Background | Nurmik M, Ullmann P, Rodriguez F, Haan S, Letellier E. In search of definitions: Cancer-associated fibroblasts and their markers. Int J Cancer. 2020 Feb 15;146(4):895-905. doi: 10.1002/ijc.32193. Epub 2019 Feb 28. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |