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

NCT05369221 | Completed Phase 1 DMC

• 1 other identifier: RN-CT-001-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical Cancer; hydrogel spacer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Implantation success rate of hydrogel spacer

  during procedure

• Evaluation of device performance of hydrogel spacer

  during procedure

• Injection volume of hydrogel spacer

  during procedure

Study Arms (1)

ReSpace™

EXPERIMENTAL

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™

Interventions

ReSpace™ DEVICE

All of the subjects will be injected with ReSpace™ hydrogel.

ReSpace™

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Shanghai Reunion Biotech Co.,Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (3)

• 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.

  PMID: 22484226 BACKGROUND

• 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.

  PMID: 30237814 BACKGROUND

• 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.

  PMID: 31034570 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: May 11, 2022
• Study Start: April 25, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)