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

NCT ID: NCT04970498

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer Stage II Rectal Cancer Stage III

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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acute myelosuppression group

WBC \<4.0×10\^9 14 days after radiotherapy

MRI

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

chronic myelosuppression group

WBC \<4.0×10\^9 90 days after radiotherapy

MRI

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

no myelosuppression group

WBC \>4.0×10\^9 during radiotherapy

MRI

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

Interventions

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MRI

MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed

Intervention Type DIAGNOSTIC_TEST

blood routine test

The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ning Lang, Professor

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Peking University third hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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宁 朗, Professor

Role: CONTACT

13501241339

Ning 朗, Professor

Role: CONTACT

13501241339

Facility Contacts

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Ning Lang

Role: primary

+861082265571

Other Identifiers

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M2021111

Identifier Type: -

Identifier Source: org_study_id

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