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

NCT ID: NCT05369221

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2023-10-10

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.

Conditions

Uterine Cervical Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ReSpace™

Intervention Type: DEVICE

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

Interventions

ReSpace™

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Reunion Biotech Co.,Ltd.

UNKNOWN

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 22484226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30237814 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31034570 (View on PubMed)

Other Identifiers

RN-CT-001-1

Identifier Type: -

Identifier Source: org_study_id