[68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer

NCT05903807 | Recruiting Phase 2

• 1 other identifier: EU CT nr: 2023-505938-98-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Fifty (n=50) patients with newly diagnosed ovarian cancer will undergo FAPI PET/CTs in addition to routine diagnostic workup (including FDG PET/CT) at primary staging and restaging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

Conditions

Ovarian Cancer

Keywords

Cancer; FAPI; FAPI PET/CT; Fibroblast activation protein inhibitor; Ovarian cancer

Outcome Measures

Primary Outcomes (3)

• Diagnostic accuracy

  Diagnostic accuracy Compare the FAPI PET/CT and FDG PET/CT findings in primary tumor, regional lymph nodes and distant metastases to a histopathological reference standard where the sensitivity, specificity, positive predicative value, and negative predicative values of the PET/CTs are determined, both at primary staging and at restaging

  2 years

• Staging

  Compare the cancer stage as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging and at restaging (after neoadjuvant chemotherapy). The proportion of patients downstaged, unchanged stage, and upstaged, due to the added FAPI PET/ CT are determined.

  2 years

• Patient management

  Investigate what proportion of patients will be (hypothetically) treated differently due to an added FAPI PET/CT at primary staging and at restaging (after neoadjuvant chemotherapy) by the treating clinicians

  2 - 2.5 years

Secondary Outcomes (5)

• Uptake values

  2 years

• Chemotherapy effect on uptake values

  2 - 2.5 years

• Unexpected 68Ga-FAPI-46 PET/CT findings

  1-2 years

• Interobserver readability

  4 years

• Prognostic value

  10 years

Study Arms (1)

Ovarian cancer or high risk of ovarian cancer

EXPERIMENTAL

Patients with newly diagnosed ovarian cancer or high risk of ovarian cancer undergo FAPI PET/CT in addition to conventional imaging

Drug: 68Ga-FAPi-46

Interventions

68Ga-FAPi-46 DRUG

Ovarian cancer patients undergo 68Ga-FAPI-46 at primary staging and at restaging

Ovarian cancer or high risk of ovarian cancer

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed with biopsy verified ovarian cancer or highly suspected to have ovarian cancer (based on all data presented at the gynecological cancer MDT) and referred to primary staging with FDG PET/CT
• Deemed resectable and operable at the MDT with or without neoadjuvant chemotherapy
• Considered physically and mentally able to participate in the research project
• years or older and able to consent to project participation
• Can read and understand Danish

You may not qualify if:

• Patients with non-resectable, inoperable, or recurrent ovarian cancer
• Patients with an imminent need for surgery or in an emergency
• Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer
• Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery
• Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
• History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46.
• Severe claustrophobia unresponsive to oral anxiolytics
• Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
• Pregnant, lactating, or breastfeeding women.
• Potential pregnant women of childbearing potential \[1\] not using effective contraceptives \[2\]. Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG)) or serum b-HCG within 48 hours prior to the FAPI PET/CT.
• Inability to remain still for the duration of the examination
• Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, i.e., not sterilized (bilateral tubectomy/occlusion, hysterectomy, bilateral oophorectomy) and not post-menopausal. In cases of uncertain menopausal status, serum follicle stimulating hormone (FSH) levels and menstruation history can be assessed
• Effective contraceptives include sexual abstinence, vasectomized partner, combined hormonal contraception (oral, intravaginal, transdermal), progesterone-only contraceptive (oral, injectable, implantable), or working intrauterine device (hormonal, non-hormonal).

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Related Publications (13)

• Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A, Mier W, Adeberg S, Rathke H, Rohrich M, Winter H, Plinkert PK, Marme F, Lang M, Kauczor HU, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019 Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6.

  PMID: 30954939 BACKGROUND

• Lindner T, Loktev A, Altmann A, Giesel F, Kratochwil C, Debus J, Jager D, Mier W, Haberkorn U. Development of Quinoline-Based Theranostic Ligands for the Targeting of Fibroblast Activation Protein. J Nucl Med. 2018 Sep;59(9):1415-1422. doi: 10.2967/jnumed.118.210443. Epub 2018 Apr 6.

  PMID: 29626119 BACKGROUND

• Kessler L, Ferdinandus J, Hirmas N, Bauer S, Dirksen U, Zarrad F, Nader M, Chodyla M, Milosevic A, Umutlu L, Schuler M, Podleska LE, Schildhaus HU, Fendler WP, Hamacher R. 68Ga-FAPI as a Diagnostic Tool in Sarcoma: Data from the 68Ga-FAPI PET Prospective Observational Trial. J Nucl Med. 2022 Jan;63(1):89-95. doi: 10.2967/jnumed.121.262096. Epub 2021 Apr 30.

  PMID: 33931468 BACKGROUND

• Rohrich M, Naumann P, Giesel FL, Choyke PL, Staudinger F, Wefers A, Liew DP, Kratochwil C, Rathke H, Liermann J, Herfarth K, Jager D, Debus J, Haberkorn U, Lang M, Koerber SA. Impact of 68Ga-FAPI PET/CT Imaging on the Therapeutic Management of Primary and Recurrent Pancreatic Ductal Adenocarcinomas. J Nucl Med. 2021 Jun 1;62(6):779-786. doi: 10.2967/jnumed.120.253062. Epub 2020 Oct 23.

  PMID: 33097632 BACKGROUND

• Dendl K, Schlittenhardt J, Staudinger F, Kratochwil C, Altmann A, Haberkorn U, Giesel FL. The Role of Fibroblast Activation Protein Ligands in Oncologic PET Imaging. PET Clin. 2021 Jul;16(3):341-351. doi: 10.1016/j.cpet.2021.03.012.

  PMID: 34053578 BACKGROUND

• Qin C, Song Y, Gai Y, Ruan W, Liu Q, Liu F, Zheng D, Zhang P, Liu H, Zhang T, Tao K, Lan X. Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4228-4240. doi: 10.1007/s00259-022-05847-0. Epub 2022 Jun 3.

  PMID: 35657428 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.

  PMID: 31836685 BACKGROUND

• Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.

  PMID: 26511519 BACKGROUND

• Zheng W, Liu L, Feng Y, Wang L, Chen Y. Comparison of 68 Ga-FAPI-04 and fluorine-18-fluorodeoxyglucose PET/computed tomography in the detection of ovarian malignancies. Nucl Med Commun. 2023 Mar 1;44(3):194-203. doi: 10.1097/MNM.0000000000001653. Epub 2022 Dec 7.

  PMID: 36472415 BACKGROUND

• Liu S, Feng Z, Xu X, Ge H, Ju X, Wu X, Song S. Head-to-head comparison of [18F]-FDG and [68 Ga]-DOTA-FAPI-04 PET/CT for radiological evaluation of platinum-sensitive recurrent ovarian cancer. Eur J Nucl Med Mol Imaging. 2023 Apr;50(5):1521-1531. doi: 10.1007/s00259-022-06096-x. Epub 2023 Jan 10.

  PMID: 36624168 BACKGROUND

• Dendl K, Koerber SA, Finck R, Mokoala KMG, Staudinger F, Schillings L, Heger U, Rohrich M, Kratochwil C, Sathekge M, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI-PET/CT in patients with various gynecological malignancies. Eur J Nucl Med Mol Imaging. 2021 Nov;48(12):4089-4100. doi: 10.1007/s00259-021-05378-0. Epub 2021 May 29.

  PMID: 34050777 BACKGROUND

• Xi Y, Sun L, Che X, Huang X, Liu H, Wang Q, Meng H, Miao Y, Qu Q, Hai W, Li B, Feng W. A comparative study of [68Ga]Ga-FAPI-04 PET/MR and [18F]FDG PET/CT in the diagnostic accuracy and resectability prediction of ovarian cancer. Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2885-2898. doi: 10.1007/s00259-023-06235-y. Epub 2023 Apr 24.

  PMID: 37093313 BACKGROUND

• Bentestuen M, Ladekarl M, Knudsen A, Zacho HD. Diagnostic accuracy and clinical value of [68Ga]Ga-FAPI-46 PET/CT for staging patients with ovarian cancer: study protocol for a prospective clinical trial. BMC Cancer. 2024 Jun 7;24(1):699. doi: 10.1186/s12885-024-12461-w.

  PMID: 38849741 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

FAPI-46

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Morten Bentestuen, MD

CONTACT

+4597665500; m.bentestuen@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Fifty consecutive patients newly diagnosed with ovarian cancer are recruited

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 15, 2023
• Study Start: November 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2035
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)