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NCT Number: NCT06653452

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Zhaoxia Huang, B.S.

CONTACT

[email protected]

86+18929673449

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic performance including sensitivity, specificity, accuracy

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. TNM stage changed by 68Ga-FAPI-04 PET/CT and PET/MR compared to 18F-FDG PET/CT and PET/MR.

    Time frame: Through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaoxia huang, B.S.

CONTACT

[email protected]

86+18929673449

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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