Observing changes in rectal cancer treatment using imaging
Official title: 68Ga FAPI in Total Neoadjuvant Therapy of Rectal Cancer
Run by Chang Gung Memorial Hospital · NCT06157463 · Data updated 2026-11-12
This study is trying to see how a special imaging test can show changes in rectal cancer before and after treatment to help understand how it affects patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 99 (estimated) |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Status | Recruiting |
| Started | March 8, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | July 31, 2028 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT06157463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with biopsy-proven stage II-III rectal cancer and a WHO/ECOG Performance Status of 0-1.
✕Probably not a fit
Patients with distant metastases, prior anticancer therapy, or serious concurrent diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational trial aims to monitor the changes in 68Ga FAPI signal in patients with biopsy-confirmed rectal cancer before and after total neoadjuvant therapy. It will assess the correlation between imaging parameters, immune checkpoint expression, and patient outcomes. Eligible participants will undergo standard staging work-ups, including colonoscopy and imaging studies, and will be recruited based on specific inclusion criteria related to their cancer stage and health status.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment responses in rectal cancer, potentially leading to improved patient outcomes.
How similar studies have gone: While this approach is novel in its specific application to rectal cancer, similar imaging studies have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biopsy proven newly detected adenocarcinoma of the rectum 2. Clinical stage II-III rectal cancer 3. Aged at least 18 years. No upper age limit. 4. WHO/ECOG Performance Status 0-1 5. Eligible for total neoadjuvant therapy Exclusion Criteria: 1. Distant metastases found on either CT, MR or FDG-PET 2. Prior anticancer therapy for colorectal cancer 3. Prior radiotherapy of the pelvic region 4. Other concurrent antineoplastic therapy 5. Major surgery within the last 4 weeks prior to inclusion 6. Subjects pregnant or breast feeding 7. 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) 8. Neurologic or psychiatric disorders including dementia, uncontrolled seizures, substance abuses, severe depression 9. Prior or concurrent malignancy within 3 years prior to enrolment (except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1) 10. Allergic to contrast agents or to the main ingredients or excipients of the experimental radiopharmaceutical 68Ga FAPI, including acetate, ascorbic acid and normal saline 11. Those deemed unsuitable for participation in the trial by the investigators.
Where it's running
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Chang Gung Memorial Hospital
Taoyuan, Taiwan Recruiting
Study contacts
- Principal investigator: Shih-hsin Chen, MD PhD — Chang Gung Medical Foundation
- Study coordinator: Shih-hsin Chen, MD PhD
- Email: yevgenyc@cgmh.org.tw
- Phone: 886-3-3281200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.