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Trial Title:
Application of PET/MRI in the Evaluation of the Efficacy of Neoadjuvant Therapy for Locally Advanced Rectal Cancer
NCT ID:
NCT06653452
Condition:
Locally Advanced Rectal Cancer (LARC)
Conditions: Official terms:
Rectal Neoplasms
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F-FDG PET/CT and PET/MR scan, 68Ga-FAPI-04 PET/CT and PET/MR scan
Description:
Patients with Locally Advanced Rectal Cancer underwent 68Ga-FAPI-04 PET/CT and PET/MR
scan after injection of 0.02 to 0.04 mCi/Kg×patient weight (Kg). Within 1 week before and
after the examination, 18F-FDG PET/CT and PET/MR is completed.
Arm group label:
18F-FDG PET/CT and PET/MR, 68Ga-FAPI-04 PET/CT and PET/MR
Summary:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaoxia Huang, B.S.
Phone:
86+18929673449
Email:
1261152761@qq.com
Start date:
July 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06653452
