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

November 30, 2022 updated by: Qianqian Qu
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Magnetic Resonance Multifunctional Imaging
Radiation: DKI and APT
DKI and APT in patients with ovarian malignancy before and after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DKI diffusion indicators and APT signal values
Time Frame: 2 Years
MK MD SI
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianqian Qu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 31, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Estimate)

December 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mr2022-10-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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