DKI Combined With APT for Post-treatment Assessment of Ovarian Malignancies and Correlation With XRCC2 Gene

NCT05642871 | Unknown

• 1 other identifier: mr2022-10-01
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ovarian cancer is one of the common causes of cancer death in women worldwide. Despite the continuous development of diagnostic and treatment techniques, the survival rate of ovarian cancer patients has not improved significantly, and the important reason for the high mortality rate and poor prognosis is the lack of effective means to assess the effectiveness of treatment. The methods to monitor the effectiveness of ovarian cancer treatment and dynamic risk stratification by conventional imaging or single tumour marker levels are rather limited. In recent years, DKI and APT imaging have made some achievements in evaluating the post-treatment outcome of tumours, and the quantitative parameters of DKI combined with APT as a non-invasive biological marker are expected to be an effective way to address the limitations of assessing the treatment outcome by non-invasively detecting the changes in the signal of water protons and the diffusion information of non-normally distributed water molecules in the tumour tissue to observe the changes of protein and microstructure in the tumour cells. This project aims to collect patients who have come to our hospital for treatment. This project aims to collect patients with ovarian malignancies who come to our hospital and perform DKI, APT sequence and XRCC2 gene examination before and after treatment, and to statistically analyse the obtained parameters to assess the value of DKI combined with APT in monitoring the treatment effect of ovarian malignancies and the correlation with XRCC2 gene. This will help to promote individualised and precise treatment of ovarian cancer and improve prognosis.

Conditions

Malignant Tumor of the Ovary; XRCC2 Gene Mutation

Outcome Measures

Primary Outcomes (1)

• DKI diffusion indicators and APT signal values

  MK MD SI

  2 Years

Study Arms (1)

Magnetic Resonance Multifunctional Imaging

Radiation: DKI and APT

Interventions

DKI and APT RADIATION

DKI and APT in patients with ovarian malignancy before and after treatment

Magnetic Resonance Multifunctional Imaging

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with first diagnosis of ovarian malignancy; enrolled patients receive paclitaxel + cisplatin combination chemotherapy in 3-week cycles, with efficacy assessed every 3 cycles

You may qualify if:

• No previous history of ovarian tumours or ovarian surgery; no concurrent other tumours, no history of oncology or treatment such as radiotherapy or chemotherapy; confirmed by pathological histology; receiving chemotherapy with a combination of platinum and purple shirt for at least 3 cycles; no contraindications to MRI

You may not qualify if:

• Recurrent ovarian malignancy; too old, poor physical infrastructure; severe medical comorbidity; incomplete patient data collection; lost to follow-up

Sponsors & Collaborators

• Qianqian Qu: lead

Biospecimen

Retention: SAMPLES WITH DNA

XRCC2

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

APT

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiology

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: January 31, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 31, 2025
• Last Updated: December 8, 2022

Record last verified: 2022-11