Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space

Phase 1

Completed

• Conditions: Uterine Cervical Neoplasms
• Interventions: Device: ReSpace™

• Registration Number: NCT05369221
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

In this study, 5 subjects will be enrolled and the cumulative D2cc dose for rectum during brachytherapy will be recorded as the primary outcome measures.

Detailed Description

This is a phase I prospective study of 5 patients to determine if PEG hydrogel (ReSpace™) reduces the radiation dose delivered to the rectum during radiation therapy for cervical cancer by increasing the space between the cervix and the anterior rectal wall. In the other word, the purpose of this study is to assess whether the use of ReSpace™ hydrogel results in a reduction of radiation exposure to the anterior rectum.

Study Timeline

• Study First Submitted: 2022-04-10
• Study Start: 2022-04-25
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-11
• Status Verified: 2023-10
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

• Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.
• Karnofsky score ≥ 70.
• Subjects aged ≥ 18 years and ≤ 75 years.
• Subjects must be able to cooperate in completing the entire study.
• The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.
• No contraindications to CT scanning.
• Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form.

Exclusion Criteria

• Subjects who have received prior pelvic radiotherapy.
• Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.)
• Subjects with other primary malignancies
• Subjects with contraindications to radiotherapy, as determined by the investigators
• Subjects with injection site infections.
• Subjects who are allergic to the ingredients of the device.
• Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators
• Persons with severe mental illness, cognitive impairment and thinking disorders.
• Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening
• Pregnant or lactating women or those who plan to get pregnant within the last six months
• Subjects who cannot be followed up as prescribed by the doctor
• Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReSpace™	ReSpace™	The subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria will be enrolled in this study. Subjects will undergo placement of ReSpace™ hydrogel.

Primary Outcome Measures

Name	Time	Method
The cumulative D2cc dose for rectum during brachytherapy	21 days post index procedure	The mean of the cumulative rectum D2cc dose during brachytherapy will be calculated for subjects. which will be used to validate the parameter selection for phase II sample size estimation.

Secondary Outcome Measures

Name	Time	Method
Evaluation of device performance of hydrogel spacer	during procedure	The ease of use of the test device will be evaluated by the investigator on the day of Operation. The evaluation items are as follows： 1. Whether the device is easy to assemble.; 2. Whether the process of positioning the needle is smooth and whether it is easy to position the needle.; 3. Whether the device is easy to inject and whether the injection process is smooth.
Injection volume of hydrogel spacer	during procedure	Recording the amount of hydrogel spacer injected in the subjects,which will be used to evaluate the reasonableness of the injected dose of ReSpace™ when hydrogel is injected between the rectum and cervix in women undergoing radiation therapy.
Implantation success rate of hydrogel spacer	during procedure	The success rate of hydrogel spacer implantation will be evaluated by the investigator for subjects.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China