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Application of IMU-Guided Technology in Cervical Cancer Brachytherapy: A Phase II Prospective, Open-Label, Randomized Controlled Trial

Application of IMU-Guided Technology in Cervical Cancer Brachytherapy: A Phase II Prospective, Open-Label, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091467
Enrollment
Unknown
Registered
2024-10-29
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Cervical cancer

Interventions

IMU group:IMU
Control group:None

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Cervical cancer patients receiving radical chemoradiotherapy. 2.Pathological types include cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma. 3.FIGO 2008 staging: IIA-IVA (IIA, IIB, IIIA, IIIB, IIIC, IVA). 4.Measurable cervical lesions present before brachytherapy. 5.Subjects aged 18-75 years, with a Karnofsky Performance Status (KPS) score of =70. 6.Subjects with an expected survival of more than 6 months. 7.Good cardiac, pulmonary, liver, and kidney function, with no contraindications for radiotherapy. 8.Voluntarily enrolled participants with good compliance, able to cooperate with trial observations, and have signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients who cannot or are unwilling to undergo brachytherapy. 2.Patients with concurrent acute or chronic infectious diseases, gastrointestinal diseases, severe heart failure, severe liver or kidney dysfunction, or other diseases or complications. 3.Pregnant and lactating women. 4.Individuals with allergic constitutions. 5.Newly developed cardiovascular and cerebrovascular diseases within the last three months. 6.Individuals with coagulation disorders or abnormal immune systems. 7.Individuals with a history of positive serological testing for human immunodeficiency virus (HIV) detected through laboratory screening. 8.The investigator believes that there is any clinically significant history of disease or disorder that may put the patient at risk, affect the results, or impair the patient's ability to participate in the study (based on the interview).

Design outcomes

Primary

MeasureTime frame
incidence of adverse events;clinical efficacy evaluation;

Secondary

MeasureTime frame
HRCTV D90 dose, rectum and bladder D2cc dose, number of interstitial needles, number of CT scans;

Countries

China

Contacts

Public ContactLiang Yang

Shanghai First Maternity and Infant Hospital

zhangran1@51mch.com+86 21 20261212

Outcome results

None listed

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