Using PET/MRI to assess treatment effectiveness in advanced rectal cancer
Application of PET/MRI in the Evaluation of the Efficacy of Neoadjuvant Therapy for Locally Advanced Rectal Cancer
This study is testing whether advanced imaging techniques like PET/MRI can better show how well treatment is working for people with locally advanced rectal cancer before their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06653452 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of neoadjuvant therapy in patients with locally advanced rectal cancer (LARC) by utilizing PET/CT and PET/MRI imaging techniques. Patients will undergo imaging before treatment and again before surgery to assess changes in the tumor and surrounding tissues. The study aims to compare the predictive efficacy of different imaging modalities, including 18F-FDG and 68Ga-FAPI PET/MRI, against traditional PET/CT and rectal MRI. The ultimate goal is to determine the value of PET/MRI in predicting treatment outcomes based on pathological findings post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed rectal adenocarcinoma who have not received prior treatment.
Not a fit: Patients with an ECOG score greater than 2 or those with multiple primary colorectal cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment of treatment efficacy for patients with locally advanced rectal cancer, potentially guiding better therapeutic decisions.
How similar studies have performed: While the use of PET/MRI in cancer evaluation is gaining traction, this specific application in LARC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Age 18-75 years old; (2) ECOG score 0-2; (3) Pathologically confirmed as rectal adenocarcinoma; (4) The lower edge of the tumor is within 12cm from the anal edge; (5) Clinically staged as cT3-4N0M0 or cTanyN+M0; (6) Untreated patients who have not received radiotherapy, chemotherapy, and surgery, etc.; (7) Good liver and kidney function, can tolerate radiotherapy and surgery; (8) Patients and their families can understand the research plan, voluntarily participate in this research and sign the informed consent form. Exclusion Criteria: * (1) ECOG score \> 2; (2) Patients with multiple primary colorectal cancers; (3) Patients with a history of other malignant tumors within the past 5 years (except for cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically removed breast ductal carcinoma in situ); (4) Patients with intestinal obstruction, intestinal perforation, gastrointestinal bleeding, and other emergencies requiring emergency surgery; (5) Pregnant or lactating women; (6) Patients with a history of severe mental illness, immune diseases, and hormone medication; (7) Patients with contraindications for MRI, PET examination, radiotherapy, immunotherapy, or surgical treatment; (8) Patients who have participated in other clinical studies within the last 3 months; (9) Any other conditions deemed unsuitable for inclusion by the researcher.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhaoxia huang, B.S.
- Email: 1261152761@qq.com
- Phone: 86+18929673449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.