Application of MRI in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer

Rectal Cancer Stage III Clinical Trial

Official title:

Application of MRI Quantitative Parameters in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970498
• Other study ID #: M2021111
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: ? ?, Professor
• Phone: 13501241339
• Email: 13501241339[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rectal cancer patients who received neoadjuvant chemoradiotherapy in Peking University Third Hospital in 2021 are divided into acute myelosuppression group, chronic myelosuppression group and normal group. The differences of magnetic resonance parameters between the groups were compared. The risk identification model of acute and chronic myelosuppression after neoadjuvant chemoradiotherapy was established by clinical risk factors and quantitative parameters of magnetic resonance imaging, and the prediction efficiency of the model was evaluated.

Description:

The patients with locally advanced rectal cancer diagnosed in Peking University Third Hospital and undergoing neoadjuvant chemoradiotherapy were collected. The basic information of patients (including age, sex, BMI, TNM stage of rectal cancer (T2, T3 stage)) was collected. The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy. MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed, and the corresponding parameters were obtained. The white blood cell values and quantitative parameters of magnetic resonance (including T1WI, DWI signal intensity (b = 1000) and proton density fat fraction (PDFF) of sacrilium and proximal femur were collected. Patients were divided into acute myelosuppression group and non-acute myelosuppression group according to blood routine results 14 days after radiotherapy, and chronic myelosuppression group and non-chronic myelosuppression group according to blood routine results 90 days after radiotherapy. The magnetic resonance parameters difference between 1-2 weeks after radiotherapy and before radiotherapy, and the magnetic resonance parameters difference between 90 days after radiotherapy and before radiotherapy were calculated. By comparing the differences of clinical risk factors and quantitative parameters of MRI between the two groups, the meaningful variables were screened out, and the risk identification model of acute and chronic myelosuppression was established.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• From February 2021 to August 2022, patients with locally advanced rectal cancer were treated with neoadjuvant chemoradiotherapy in the Third Hospital of Peking University.
• There were blood routine before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy, and MRI examination including routine MRI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks and 90 days after radiotherapy.
• Each patient used the same chemotherapy regimen.

Exclusion Criteria:

• Patients with metabolic bone diseases such as hyperparathyroidism and Cushing's syndrome.
• Patients with history of pelvic radiotherapy or systemic chemotherapy.
• Patients with leukocytes below 4.0×10^9/L or long-term severe anemia before radiotherapy.
• Patients with tumor bone metastases; patients with pelvic trauma, fracture, and infectious diseases.

Related Conditions & MeSH terms

• Rectal Cancer Stage II
• Rectal Cancer Stage III
• Rectal Neoplasms

Intervention

Diagnostic Test:
• MRI
MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed
• blood routine test
The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

Locations

Country	Name	City	State
China	Peking University third hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of IDEAL-IQ sequence of MRI	The differences of PDFF(%) between the acute myelosuppression group and no suppression group	1-2 weeks after radiotherapy
Primary	Changes of T1WI sequence of MRI	The differences of T1WI signal intensity(IU) between the acute myelosuppression group and no suppression group	1-2 weeks after radiotherapy
Primary	Changes of DWI sequence of MRI	The differences of DWI signal intensity(IU)between the acute myelosuppression group and no suppression group	1-2 weeks after radiotherapy
Primary	Changes of ADC map of MRI	The differences of ADC value(mm^2/s) between the acute myelosuppression group and no suppression group	1-2 weeks after radiotherapy
Primary	Changes of IDEAL-IQ sequence of MRI	The differences of PDFF(%) between the chronic myelosuppression group and no suppression group	90 days after radiotherapy
Primary	Changes of T1WI sequence of MRI	The differences T1WI signal intensity(IU)between the chronic myelosuppression group and no suppression group	90 days after radiotherapy
Primary	Changes of DWI sequence of MRI	The differences of DWI signal intensity(IU)between the chronic myelosuppression group and no suppression group	90 days after radiotherapy
Primary	Changes of ADC map of MRI	The differences of ADC value(mm^2/s) between the chronic myelosuppression group and no suppression group	90 days after radiotherapy