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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Device: ReSpace™

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: ReSpace™; All of the subjects will be injected with ReSpace™ hydrogel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cumulative D2cc dose for rectum during brachytherapy	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.	21 days post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation success rate of hydrogel spacer	The success rate of hydrogel spacer implantation will be evaluated by the investigator for subjects.	during procedure
Evaluation of device performance of hydrogel spacer	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： Whether the device is easy to assemble.; Whether the process of positioning the needle is smooth and whether it is easy to position the needle.; Whether the device is easy to inject and whether the injection process is smooth.	during procedure
Injection volume of hydrogel spacer	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.	during procedure

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Shanghai Reunion Biotech Co.,Ltd.

Publications and helpful links

General Publications

• de Freitas AC, Gurgel AP, Chagas BS, Coimbra EC, do Amaral CM. Susceptibility to cervical cancer: an overview. Gynecol Oncol. 2012 Aug;126(2):304-11. doi: 10.1016/j.ygyno.2012.03.047. Epub 2012 Apr 4.
• Peach MS, Moore J, Giles W, Trainor J, Long T, Moon N, Hylton JE, Showalter TN, Libby B. Development and preclinical testing of a novel biodegradable hydrogel vaginal packing technology for gynecologic high-dose-rate brachytherapy. J Contemp Brachytherapy. 2018 Aug;10(4):306-314. doi: 10.5114/jcb.2018.77952. Epub 2018 Aug 31.
• Kashihara T, Murakami N, Tselis N, Kobayashi K, Tsuchida K, Shima S, Masui K, Yoshida K, Takahashi K, Inaba K, Umezawa R, Igaki H, Ito Y, Kato T, Uno T, Itami J. Hyaluronate gel injection for rectum dose reduction in gynecologic high-dose-rate brachytherapy: initial Japanese experience. J Radiat Res. 2019 Jul 1;60(4):501-508. doi: 10.1093/jrr/rrz016.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cervical Cancer; hydrogel spacer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: RN-CT-001-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No