Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-13 @ 1:25 PM
Study NCT ID:
NCT06769828
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, Specificity, and Accuracy of Ga-68-FAPI-46 PET for CRC Recurrence Detection', 'timeFrame': 'Within 6 months of PET imaging.', 'description': 'Evaluate the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence. Pathological results will be used as the reference standard where available, or clinical follow-up will be used in cases where tissue sampling is not feasible.'}, {'measure': 'Comparison of Ga-68-FAPI-46 PET and FDG PET in CRC Recurrence Detection', 'timeFrame': 'Within 6 months of PET imaging.', 'description': 'Compare the diagnostic performance of Ga-68-FAPI-46 PET and F-18-FDG PET in detecting colorectal cancer recurrence, including sensitivity, specificity, and accuracy.'}], 'secondaryOutcomes': [{'measure': 'Clinical Impact of Ga-68-FAPI-46 PET on Management Decisions', 'timeFrame': 'Immediately after completion of PET imaging and report review.', 'description': 'Evaluate the impact of Ga-68-FAPI-46 PET imaging on clinical decision-making through a questionnaire completed by the principal investigator before and after receiving the PET results. The questionnaire assesses changes in diagnosis, treatment planning, and patient management.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ga-68-FAPI-46 PET/CT', 'Colorectal cancer (CRC)'], 'conditions': ['Colorectal Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.', 'detailedDescription': 'Colorectal cancer (CRC) is one of the leading causes of cancer-related mortality, with a significant recurrence rate following curative surgery, particularly in stages II and III. Early detection of asymptomatic recurrence is critical for initiating salvage treatment. Serum CEA elevation is a marker for recurrence, necessitating advanced imaging tools for precise localization.\n\nThis study evaluates the use of Ga-68-FAPI-46, a novel imaging agent targeting fibroblast activation protein (FAP), which is overexpressed in the tumor stroma. Ga-68-FAPI-46 demonstrates higher tumor uptake and faster clearance from normal tissues compared to F-18-FDG, offering a potential diagnostic advantage. Participants will undergo both F-18-FDG PET and Ga-68-FAPI-46 PET scans, with lesion detection validated through pathology or clinical follow-up.\n\nThe trial aims to determine the diagnostic performance of Ga-68-FAPI-46 PET in terms of sensitivity, specificity, positive predictive value, and negative predictive value, using the McNemar test for statistical comparison. The study also emphasizes participant safety and data protection, adhering to Good Clinical Practice (GCP) guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years old\n* The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies.\n* Elevated serum CEA levels:\n\nExceeding the laboratory\'s normal range (5 ng/ml) or, but not surpassing 13 ng/ml; using the individual\'s post-surgery +/- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence.\n\n* Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.\n* Signing the subject consent form.\n* ECOG grade 0-2.\n* The timing of F-18-FDG usage in this trial follows the " 2023 - Colorectal Cancer Treatment Principles" of our institution.\n\nExclusion Criteria:\n\n* pregnant woman and breastfeeding women\n* severe renal impairment (eGRF\\< 30ml/min)\n* Known or suspected allergy to radiopharmaceuticals\n* Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.\n* Inability to undergo the necessary PET scan procedure\n* Refusal or unwillingness to sign the informed consent form\n* Severe medical conditions (severe disabilities, mental disorders)'}, 'identificationModule': {'nctId': 'NCT06769828', 'acronym': 'Ga-68-FAPI-46', 'briefTitle': 'Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA', 'organization': {'class': 'OTHER', 'fullName': 'Koo Foundation Sun Yat-Sen Cancer Center'}, 'officialTitle': 'Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance', 'orgStudyIdInfo': {'id': 'KF-FAPI46-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ga-68-FAPI-46 PET scan in colorectal cancer', 'description': 'Participants in this arm will undergo a Ga-68-FAPI-46 PET scan within 2-14 days after their F-18-FDG PET scan. Ga-68-FAPI-46 will be administered via intravenous injection at a dose of 1.8-2.2 MBq per kilogram of body weight, with a maximum dose of 200 MBq. The scan will be performed 30-90 minutes after injection. This study aims to evaluate the diagnostic performance of Ga-68-FAPI-46 PET in detecting colorectal cancer recurrence in patients with elevated serum carcinoembryonic antigen (CEA), compared to F-18-FDG PET.', 'interventionNames': ['Drug: Ga-68-FAPI-46']}], 'interventions': [{'name': 'Ga-68-FAPI-46', 'type': 'DRUG', 'otherNames': ['PET/CT'], 'description': 'Ga-68-FAPI-46 PET scan in colorectal cancer', 'armGroupLabels': ['Ga-68-FAPI-46 PET scan in colorectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1125019', 'city': 'Taipei', 'state': 'Beitou', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu Yi Huang, MD', 'role': 'CONTACT', 'email': 'yuyi@kfsyscc.org', 'phone': '+886 28970011', 'phoneExt': '1121'}, {'name': 'Cheng Ling Yang, B.Rad.', 'role': 'CONTACT', 'email': 'androgyny@kfsyscc.org', 'phone': '+886 28970011', 'phoneExt': '1167'}], 'facility': 'Koo Foundation Sun Yat-Sen Cancer Center', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yu Yi Huang, MD', 'role': 'CONTACT', 'email': 'yuyi@kfsyscc.org', 'phone': '+886 28970011', 'phoneExt': '1121'}, {'name': 'Cheng Ling Yang, B.Rad.', 'role': 'CONTACT', 'email': 'androgyny@kfsyscc.org', 'phone': '+886 28970011', 'phoneExt': '1167'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koo Foundation Sun Yat-Sen Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}