Clinical trial · Interventional
[68Ga]Ga-FAPI PET/CT in Gastric and Gastroesophageal Junctional Cancer
[68Ga]Ga-FAPI PET/CT: The Dagnostic Accuracy for Primary Staging and Re-staging After Chemotherapy in Patients With Gastric and Gastro-esophageal Junctional Cancer
NCT05898854CI-TRIAL-00099857completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastro Esophageal Junctional Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPi-46 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gastric or gastro-esophageal junctioncancer
- description
- Patients with biopsy verified gastric or gastro-esophageal junction cancer undergo FAPI PET/CT in addition to conventional imaging
- interventionNames
- Drug: 68Ga-FAPi-46
Primary outcomes (3)
- measure
- Diagnostic accuracy
- timeFrame
- 1.5 years
- description
- 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
- measure
- Staging
- timeFrame
- 1.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 18-years or older and able to consent to project participation Exclusion Criteria: * 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 1. 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. 2. 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).
References
Publications (15)
- BACKGROUNDKratochwil 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
- BACKGROUNDLindner 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
- BACKGROUNDKessler 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
- BACKGROUNDRohrich 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
- BACKGROUNDDendl 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
- BACKGROUNDPang 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.