Using FAPI PET/CT to improve diagnosis in gastric 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
PHASE2 · Aalborg University Hospital · NCT05898854
This study is testing a new type of imaging called FAPI PET/CT to see if it can better diagnose gastric cancer compared to standard imaging methods.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aalborg, Region Nordjylland) |
| Trial ID | NCT05898854 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 20 patients with gastric or gastro-esophageal junctional cancer who will undergo FAPI PET/CT imaging alongside standard diagnostic procedures, including FDG PET/CT. The study aims to compare the effectiveness of FAPI PET/CT against conventional imaging methods, using histopathology as the reference standard to determine diagnostic accuracy. Additionally, the trial will evaluate how FAPI PET/CT influences patient management and its prognostic value. The innovative use of a new PET-tracer, Gallium-68 labelled fibroblast activation protein inhibitor (FAPI), is central to this investigation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, biopsy-verified gastric or gastro-esophageal junctional cancer who are deemed operable.
Not a fit: Patients with non-resectable or recurrent gastric cancer, or those with other concurrent malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnosis and better management of gastric cancer.
How similar studies have performed: While FAPI PET/CT has shown promising results in preliminary studies, further research is needed to establish its role compared to established imaging techniques like FDG PET/CT.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Aalborg, Region Nordjylland
- Aalborg University Hospital — Aalborg, Region Nordjylland, Denmark (RECRUITING)
Study contacts
- Study coordinator: Morten Bentestuen, MD
- Email: m.bentestuen@rn.dk
- Phone: +45 97665500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Cancer, Gastro Esophageal Junctional Cancer, Cancer, PET/CT, Fibroblast activation protein inhibitor, FAPI, FAPI PET/CT