Status:
RECRUITING
FAPI in Rectal Cancer TNT
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
National Science and Technology Council
Conditions:
Rectal Neoplasms Malignant
Eligibility:
All Genders
18+ years
Brief Summary
The goal of the trial is to observe the changes of 68Ga FAPI signal before and after total neoadjuvant therapy for rectal cancers, and the correlation between the image parameters, immune checkpoints ...
Eligibility Criteria
Inclusion
- Biopsy proven newly detected adenocarcinoma of the rectum
- Clinical stage II-III rectal cancer
- Aged at least 18 years. No upper age limit.
- WHO/ECOG Performance Status 0-1
- Eligible for total neoadjuvant therapy
Exclusion
- Distant metastases found on either CT, MR or FDG-PET
- Prior anticancer therapy for colorectal cancer
- Prior radiotherapy of the pelvic region
- Other concurrent antineoplastic therapy
- Major surgery within the last 4 weeks prior to inclusion
- Subjects pregnant or breast feeding
- Serious concurrent diseases not compatible with study entry, including active, uncontrolled infections, active, disseminated coagulation disorder, clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia within 6 months before enrolment)
- Neurologic or psychiatric disorders including dementia, uncontrolled seizures, substance abuses, severe depression
- Prior or concurrent malignancy within 3 years prior to enrolment (except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1)
- Allergic to contrast agents or to the main ingredients or excipients of the experimental radiopharmaceutical 68Ga FAPI, including acetate, ascorbic acid and normal saline
- Those deemed unsuitable for participation in the trial by the investigators.
Key Trial Info
Start Date :
March 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06157463
Start Date
March 8 2024
End Date
July 31 2028
Last Update
August 7 2024
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 333