Ga-68-FAPI-46 PET for CRC Recurrence Detection in Elevated CEA
NCT ID: NCT06769828
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-02-01
2026-04-14
Brief Summary
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Detailed Description
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This 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.
The 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ga-68-FAPI-46 PET scan in colorectal cancer
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.
Ga-68-FAPI-46
Ga-68-FAPI-46 PET scan in colorectal cancer
Interventions
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Ga-68-FAPI-46
Ga-68-FAPI-46 PET scan in colorectal cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Elevated serum CEA levels:
Exceeding 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.
* Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.
* Signing the subject consent form.
* ECOG grade 0-2.
* The timing of F-18-FDG usage in this trial follows the " 2023 - Colorectal Cancer Treatment Principles" of our institution.
Exclusion Criteria
* severe renal impairment (eGRF\< 30ml/min)
* Known or suspected allergy to radiopharmaceuticals
* Simultaneously or previously diagnosed with malignant tumors other than colorectal cancer.
* Inability to undergo the necessary PET scan procedure
* Refusal or unwillingness to sign the informed consent form
* Severe medical conditions (severe disabilities, mental disorders)
20 Years
100 Years
ALL
No
Sponsors
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Koo Foundation Sun Yat-Sen Cancer Center
OTHER
Responsible Party
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Locations
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Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Beitou, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KF-FAPI46-001
Identifier Type: -
Identifier Source: org_study_id
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