Application of PET/MRI in the Evaluation of the Efficacy of Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Locally Advanced Rectal Cancer (LARC)

Treatments: Diagnostic Test: 18F-FDG PET/CT and PET/MR scan, 68Ga-FAPI-04 PET/CT and PET/MR scan

Study type: Interventional

Funder types: Other

Identifiers

NCT06653452

PUMCH-NM-LARC-FAPI

Details and patient eligibility

About

This study plans to include LARC patients receiving neoadjuvant therapy at this center, conducting PET/CT and PET/MR examinations before treatment, and PET/MR examinations before surgery after neoadjuvant therapy. The changes in the lesion before and after treatment will be compared to evaluate the efficacy of neoadjuvant therapy, including: the relief situation of the rectal primary lesion ; lymph node metastasis; local infiltration around the tumor; peritoneal and other distant metastases , etc. The pathological relief diagnosed by surgical pathology is the gold standard, and the predictive efficacy of PET/MR will be evaluated, comparing the advantages and disadvantages of 18F-FDG and 68Ga-FAPI PET/MR, and comparing with traditional PET/CT and rectal MRI to explore the value of PET/MRI in predicting the efficacy of neoadjuvant therapy in LARC patients.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

18F-FDG PET/CT and PET/MR, 68Ga-FAPI-04 PET/CT and PET/MR

Experimental group

Description:

After patient enrollment, 68Ga-FAPI-04 PET/CT and PET/MR examinations are performed. Within 1 week before and after the examination, PET/CT and PET/MR is also performed in patients.

Treatment:

Diagnostic Test: 18F-FDG PET/CT and PET/MR scan, 68Ga-FAPI-04 PET/CT and PET/MR scan