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Predictive Value of PET/MRI for Pathological Complete Remission after Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer: a Prospective, Diagnostic Study

Predictive Value of PET/MRI for Pathological Complete Remission after Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer: a Prospective, Diagnostic Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063005
Enrollment
Unknown
Registered
2022-08-27
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Interventions

Gold Standard:Pathological examination before initial treatment and post operation.
Index test:PET/MRI

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old; Male, or non-pregnant and non-lactating women; 2. Pathologically diagnosed rectal adenocarcinoma, the tumor is less than 12 cm from the anus; 3. The stage is local late stage, i.e. T3-4N0M0 or TanyN+M0; 4. According to NCCN or CSCO diagnosis and treatment guidelines, it is planned to receive sequential surgical treatment with neoadjuvant radiotherapy and chemotherapy; 5. Initial treatment, and has not yet received any anti-tumor treatment; 6. Generally in good condition: KPS >= 70 or ECOG PS 0-1; 7. Blood routine: WBC >= 4 x 10^9/L, Platelet >= 100 x 10^9/L, HB >= 90 g/L; 8. Liver function: ALT, AST, ALP, TBil = 28 g/L; 9. Renal function: creatinine clearance rate >= 50 ml/min; 10. The estimated survival time is more than 3 months; 11. The patient agreed to join the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous history of other malignant tumors; 2. Suffering from other uncontrolled serious diseases at the same time, such as unstable heart disease, kidney disease, chronic hepatitis with abnormal liver function, poorly controlled diabetes (fasting blood sugar > 1.5 x upper limit of normal value), mental illness And a history of severe allergies, or other diseases judged by the researchers that may affect the conduct of this study; 3. There are contraindications for PET/MRI examination; 4. There are clear contraindications to radiotherapy and chemotherapy; 5. There are clear contraindications to surgery or anesthesia.

Design outcomes

Primary

MeasureTime frame
Estimating tumor regression by PET/MRI;Judging tumor regression by pathology;Sensitivity;Specificity;Accuracy;Receiver Operating Characteristic Curve;

Countries

China

Contacts

Public ContactZhibo Tan

Peking University Shenzhen Hospital

tanzhibo@gmail.com+86 18588456234

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026