NCT06790082 (FAPI-PM) is a Phase 2 clinical trial of [68Ga]Ga-FAPI-46 PET/CT in Pleural Mesothelioma, sponsored by Aalborg University Hospital.

Who is sponsoring NCT06790082?

NCT06790082 is sponsored by Aalborg University Hospital.

What drugs are being tested in NCT06790082?

Interventions in NCT06790082: [68Ga]Ga-FAPI-46 PET/CT.

What condition does NCT06790082 study?

NCT06790082 studies Pleural Mesothelioma, Pleural Diseases, Cancer, FAPI, Fibroblast Activation Protein Inhibitor.

Is NCT06790082 still recruiting?

NCT06790082 is currently recruiting now. Last updated 3 July 2025.

Last reviewed 2025-07-03 · How we verify

NCT06790082: FAPI-PM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma

Recruiting now Phase 2 Last updated 3 July 2025

What this trial tests

Phase 2 trial testing [68Ga]Ga-FAPI-46 PET/CT in Pleural Mesothelioma in 70 participants. Currently enrolling.

Timeline

29 January 2025

Primary endpoint
30 April 2027

30 April 2037

Quick facts

Lead sponsor	Aalborg University Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	70
Start date	29 January 2025
Primary completion	30 April 2027
Estimated completion	30 April 2037
Sites	1 location across Denmark

Drugs / interventions tested

[68Ga]Ga-FAPI-46 PET/CT — full drug profile →

Conditions studied

Pleural Mesothelioma — all drugs for Pleural Mesothelioma →
Pleural Diseases — all drugs for Pleural Diseases →
Cancer — all drugs for Cancer →
FAPI — all drugs for FAPI →

Sponsor

Aalborg University Hospital

Who can join

18 and older, any sex, with Pleural Mesothelioma or Pleural Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET/CT at primary staging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT). The diagnostic accuracy will be determined with histopathology as reference standard. For patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET/CT and an additional FDG PET/CT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET/CT in response evaluation will be investigated. All study specific analyzes will be blinded and will not influence the patient management / treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

FDG and FAPI PET-based response evaluation to reduced-dose nivolumab in pleural mesothelioma: A case report.
Bentestuen M, Thostrup AH, Szejniuk WM, Takacs-Szabo Z, et al · · 2026 · PMID 41715997 · DOI 10.1111/cpf.70053
Pleural Mesothelioma Diagnosis for the Pulmonologist: Steps Along the Way.
Fantin A, Castaldo N, Crisafulli E, Sartori G, et al · · 2025 · PMID 41375066 · DOI 10.3390/cancers17233866

Verify or expand the search:

Other trials of [68Ga]Ga-FAPI-46 PET/CT

Trials testing the same drug.

NCT05957250 — [68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer · NA · recruiting

Other recruiting trials for Pleural Mesothelioma

Currently open trials in the same condition.

NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting
NCT06362369 — A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy · Phase 1, PHASE2 · recruiting
NCT06410625 — Evaluation of Response by FLT PET in Mesothelioma · NA · recruiting
NCT05086692 — A Beta-only IL-2 ImmunoTherapY Study · Phase 1, PHASE2 · recruiting

Other Aalborg University Hospital trials

Trials by the same sponsor.

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NCT07185958 — Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy · not yet recruiting
NCT07165574 — Prevalence of Anticholinergics in Geriatric Patients With Acute Functional Deterioration · not yet recruiting
NCT07173413 — Assessing the Quality of Telephone Follow-Up After Spine Surgery · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06790082 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aalborg University Hospital
Last refreshed: 3 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06790082.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing