Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT07217704
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-10-14', 'studyFirstSubmitQcDate': '2025-10-15', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity for detection of distant metastatic disease (M1) using a composite SOT as reference', 'timeFrame': 'From enrollment to the end of treatment after 3 month follow up', 'description': 'To evaluate the diagnostic performance of \\[¹⁸F\\]FAPI-74 in determining the presence or absence of metastatic disease (M1) in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancers, compared to a composite SOT'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of adverse events using CTCAE v5.', 'timeFrame': '24-72 hours post-injection', 'description': 'To assess the safety profile of \\[¹⁸F\\]FAPI-74.'}, {'measure': 'Sensitivity and specificity for the localized detection of peritoneal metastases', 'timeFrame': 'From enrollment to the end of treatment after 3 month follow up', 'description': 'To evaluate the diagnostic performance of \\[18F\\]FAPI-74 PET/CT for detecting peritoneal metastatic disease'}, {'measure': 'Comparative sensitivity and specificity between [18F]FAPI-74 and [¹⁸F]FDG PET/CT for detection of M1 disease using a composite SOT as reference', 'timeFrame': 'From enrollment to the end of treatment after 3 month follow up', 'description': 'To compare clinical accuracy of \\[18F\\]FAPI-74 PET/CT imaging to that of \\[¹⁸F\\]FDG PET/CT, for participants who have had this performed, for detection of metastatic disease.'}, {'measure': "Cohen's kappa for pairwise evaluation of inter- and intra-reader agreement", 'timeFrame': 'From enrollment to the end of treatment after 3 month follow up', 'description': 'To assess inter-and intra-reader variability in image interpretation of the presence of metastatic disease'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by body temperature changes', 'timeFrame': '24-72 hours post-injection', 'description': 'To assess the safety profile of \\[¹⁸F\\]FAPI-74'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by blood pressure changes', 'timeFrame': '24-72 hours post-injection', 'description': 'To assess the safety profile of \\[¹⁸F\\]FAPI-74'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by respiration rate', 'timeFrame': 'Time Frame: 24-72 hours post-injection', 'description': 'To assess the safety profile of \\[¹⁸F\\]FAPI-74'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by pulse rate', 'timeFrame': '24-72 hours post-injection', 'description': 'To assess the safety profile of \\[¹⁸F\\]FAPI-74'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FAP', 'Fibroblast Activation Protein', 'Fibroblast Activation Protein Inhibitor', 'FAPI', 'gastroesophageal cancer', 'PET'], 'conditions': ['Esophageal Cancer', 'Gastric Cancer (GC)', 'Gastroesophageal Junction']}, 'descriptionModule': {'briefSummary': 'This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \\[¹⁸F\\]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancer. Following screening, using a standardized administration protocol and dose, participants will undergo \\[¹⁸F\\]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \\[¹⁸F\\]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \\[¹⁸F\\]FAPI-74 PET/CT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female adults ≥ 18 years.\n* Participants with confirmed gastric, esophageal or gastroesophageal malignancy undergoing staging evaluation for treatment planning.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Provided signed, written informed consent prior to any study-related procedures.\n* Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \\[¹⁸F\\]FAPI-74 administration.\n* For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, during the trial intervention period.\n\nExclusion Criteria:\n\n* Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.\n* Known hypersensitivity to \\[¹⁸F\\]FAPI-74.\n* Administration of another investigational diagnostic or therapeutic product within 30 days prior to \\[¹⁸F\\]FAPI-74 administration.\n* Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \\[¹⁸F\\]FAPI-74 administration.\n* Previous cancer (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus (participants treated with curative intent and disease free for more than 5 years are permitted).\n* Hepatic function: T. bili \\>1.5X ULN or alk phos, ALT, or AST \\>5X ULN\n* Renal function: GFR \\< 30 mL/min\n* Pregnant or currently breast feeding (a negative pregnancy test is required in women of childbearing potential).\n* Inability to undergo the PET/CT scanning procedure.\n* Inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n* Sarcoidosis\n* Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers"}, 'identificationModule': {'nctId': 'NCT07217704', 'acronym': 'FAPI-GO', 'briefTitle': 'Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'SOFIE'}, 'officialTitle': 'A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET/CT for the Detection of Metastatic Disease in Adults With Gastric or Esophageal Cancer', 'orgStudyIdInfo': {'id': '18FFAPI-2025P3-GEC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with gastric or esophageal cancer receiving [18F]FAPI-74', 'interventionNames': ['Drug: [18F]FAPI-74 PET/CT']}], 'interventions': [{'name': '[18F]FAPI-74 PET/CT', 'type': 'DRUG', 'description': '\\[18F\\]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastric or esophageal cancers.', 'armGroupLabels': ['Patients with gastric or esophageal cancer receiving [18F]FAPI-74']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sabrina Mora', 'role': 'CONTACT', 'email': 'Sabrina.mora@heliosclinical.com', 'phone': '562-693-4477'}, {'name': 'Alexis Velasco', 'role': 'CONTACT', 'email': 'alexis.velasco@heliosclinical.com'}, {'name': 'Omkar Marathe, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helios CR Inc./RadNet', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Beth Thomsen', 'role': 'CONTACT', 'email': 'Beth.thomsen@hoag.org', 'phone': '949-557-0285'}, {'name': 'Gary Ulaner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoag Memorial Hospital', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Grubbs', 'role': 'CONTACT', 'email': 'eegrubbs@iu.edu', 'phone': '(317) 274-2584'}, {'name': 'Cindy Yuan, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Alex Osipova', 'role': 'CONTACT', 'email': 'Alex.osipova@sofie.com', 'phone': '1-800-753-5368'}, {'name': 'Bridget Adams', 'role': 'CONTACT', 'email': 'bridget.adams@sofie.com', 'phone': '1-800-753-5368'}], 'overallOfficials': [{'name': 'Sherly Mosessian, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SOFIE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SOFIE', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}