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Malignant Melanoma Stage IVPhase 2BEFASTNCT07215182

[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer

A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Malignant Melanoma Stage IV, run by Barbara Malene Fischer at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma Stage IV
What is being tested?
[68Ga]Ga-FAPI-46
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesDenmark
Study dates
15 Aug 2025to 20 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, >/=18 years old
  • Histological verified metastatic or locally advanced malignant melanoma
  • Visible malignant lesions on [18F]FDG PET/CT or CT
  • Subjects must be considered inoperable
  • Subjects must be considered medically suitable for ICT
  • Subjects must be able to read and understand the patient information in Danish to give informed consent

Who cannot join

  • Ocular or mucosal melanoma
  • Other concurrent cancer disease
  • Previous systemic oncological treatment with ICT
  • Pregnancy or lactation
  • Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
  • History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI- 46

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark2 sites, 2 recruiting

  • Rigshospitalet

    Copenhagen, Ca, 2100

    Marie MK Stolberg, MD, +4535454416, marie.manon.krebs.krarup@regionh.dk

    Barbara M. Fischer, Professor, MD, Ph.D., +4535453545, barbara.malene.fischer@regionh.dk

    Recruiting

  • Herlev Universityhospital

    Herlev, Capital Region, 2730

    Inge Marie Svane, Professor, MD, PhD, +4538683868, inge.marie.svane@regionh.dk

    Marie MK Stolberg, MD, +4535454416, marie.manon.krebs.krarup@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: [68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma

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.
Read more

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:

  • Two [68Ga]Ga-FAPI-46 PET/CT scans: one before treatment initiation with ICT and one after three months.
  • Two blood samples
  • Passive follow-up 6 months after the last scan [68Ga]Ga-FAPI-46 PET/CT
Being tested
[68Ga]Ga-FAPI-46
Keywords
FAPI PET/CT, Immune checkpoint inhibitor therapy, malignant melanoma, response evaluation
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-FAPI-46Drug

    Patients undergo two PET/CTs with the experimental tracer [68Ga]Ga-FAPI-46 (drug).

Study groups in NCT07215182
Study groupRoleWhat they receive
Advanced staged Malignant MelanomaExperimentalPatients 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.
Receives: Drug: [68Ga]Ga-FAPI-46

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months.

Secondary outcomes (1)

  1. 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study start15 Aug 2025
  3. Primary completion20 Aug 2026 (estimated)
  4. Study completion20 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215182
Sponsor's protocol ID
522_22
Other IDs
2023-509549-11-00, 2023
Acronym
BEFAST
Status last verified
Oct 2025
First submitted
10 Sep 2025
Last updated
10 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30257879

  • 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.

    PubMed 33620560

  • 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.

    PubMed 36581374

  • 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.

    PubMed 31836685

  • 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.

    PubMed 33718446

  • 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.

    PubMed 33914106

  • 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.

    PubMed 35155199

  • 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.

    PubMed 31428105

  • 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.

    PubMed 35137262

  • 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.

    PubMed 26185533

  • 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.

    PubMed 30734283

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Malignant Melanoma Stage IV, run by Barbara Malene Fischer at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT (time frame: From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215182, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.

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