[68Ga]Ga-FAPI PET/CT in Gastric and Gastroesophageal Junctional Cancer

NCT05898854 | Completed Phase 2 DMC

• 2 other identifiers: EU CTIS no.: 2023-505916-40-012023-505916-40-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty (n=20) patients with gastric cancer or gastro-esophageal junctional cancer will undergo FAPI PET/CTs in addition to routing 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

Gastric Cancer; Gastro Esophageal Junctional Cancer; Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  1.5 years

• Staging

  Compare the cancer stage (according to AJCC 8th edition TNM-classification) 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.

  1.5 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

  1.5 - 2 years

Secondary Outcomes (5)

• Uptake values

  1.5 years

• Chemotherapy effect on uptake values

  1.5 - 2 years

• Unexpected FAPI PET/CT findings

  1 -2 years

• Interobserver readability

  4 years

• Prognostic value

  10 years

Study Arms (1)

Gastric or gastro-esophageal junctioncancer

EXPERIMENTAL

Patients with biopsy verified gastric or gastro-esophageal junction cancer undergo FAPI PET/CT in addition to conventional imaging

Drug: 68Ga-FAPi-46

Interventions

68Ga-FAPi-46 DRUG

Gastric or gatro-esophageal junction cancer patients undergo 68Ga-FAPi-46 PET/CT at primary staging and at restaging

Gastric or gastro-esophageal junctioncancer

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed with biopsy verified gastric or GEJ cancer and referred to primary staging 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
• Can read and understand Danish
• years or older and able to consent to project participation

You may not qualify if:

• Patients with non-resectable, inoperable, or recurrent gastric or GEJ 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 HCG) \< 48 hours before injection with 68Ga-FAPI-46.
• 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

Location

Related Publications (15)

• 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

• Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1.

  PMID: 33258746 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

• Qin C, Shao F, Gai Y, Liu Q, Ruan W, Liu F, Hu F, Lan X. 68Ga-DOTA-FAPI-04 PET/MR in the Evaluation of Gastric Carcinomas: Comparison with 18F-FDG PET/CT. J Nucl Med. 2022 Jan;63(1):81-88. doi: 10.2967/jnumed.120.258467. Epub 2021 Apr 16.

  PMID: 33863819 BACKGROUND

• Gundogan C, Komek H, Can C, Yildirim OA, Kaplan I, Erdur E, Poyraz K, Guzel Y, Oruc Z, Cakabay B. Comparison of 18F-FDG PET/CT and 68Ga-FAPI-04 PET/CT in the staging and restaging of gastric adenocarcinoma. Nucl Med Commun. 2022 Jan 1;43(1):64-72. doi: 10.1097/MNM.0000000000001489.

  PMID: 34661379 BACKGROUND

• Jiang D, Chen X, You Z, Wang H, Zhang X, Li X, Ren S, Huang Q, Hua F, Guan Y, Zhao J, Xie F. Comparison of [68 Ga]Ga-FAPI-04 and [18F]-FDG for the detection of primary and metastatic lesions in patients with gastric cancer: a bicentric retrospective study. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):732-742. doi: 10.1007/s00259-021-05441-w. Epub 2021 Jul 23.

  PMID: 34297193 BACKGROUND

• Alan-Selcuk N, Ergen S, Demirci E, Ocak M, Kabasakal L. [68Ga]DOTA-FAPI-04 PET/CT imaging in a case of a signet ring cell carcinoma of stomach. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4523-4524. doi: 10.1007/s00259-021-05213-6. Epub 2021 Jun 19. No abstract available.

  PMID: 34148117 BACKGROUND

• Fan C, Guo W, Su G, Chen B, Chen H. Widespread Metastatic Gastric Signet-Ring Cell Carcinoma Shown by 68Ga-FAPI PET/CT. Clin Nucl Med. 2021 Feb 1;46(2):e78-e79. doi: 10.1097/RLU.0000000000003245.

  PMID: 32804764 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

• Bentestuen M, Al-Obaydi N, Zacho HD. FAPI-avid nonmalignant PET/CT findings: An expedited systematic review. Semin Nucl Med. 2023 Sep;53(5):694-705. doi: 10.1053/j.semnuclmed.2023.02.001. Epub 2023 Feb 20.

  PMID: 36813670 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

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Interventions

FAPI-46

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

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: Twenty consecutive patients newly diagnosed with gastric or gastro-esophageal junction cancer are recruited.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: February 15, 2024
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)