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

Primary Purpose

Uterine Cervical Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ReSpace™
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Cervical Cancer, hydrogel spacer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReSpace™

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Implantation success rate of hydrogel spacer
The success rate of hydrogel spacer implantation will be evaluated by the investigator for subjects.
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.
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.

Full Information

First Posted
April 10, 2022
Last Updated
May 10, 2022
Sponsor
Peking Union Medical College Hospital
Collaborators
Shanghai Reunion Biotech Co.,Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05369221
Brief Title
Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space
Official Title
Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Shanghai Reunion Biotech Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Cervical Cancer, hydrogel spacer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ReSpace™
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ReSpace™
Intervention Description
All of the subjects will be injected with ReSpace™ hydrogel.
Primary Outcome Measure Information:
Title
The cumulative D2cc dose for rectum during brachytherapy
Description
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.
Time Frame
21 days post index procedure
Secondary Outcome Measure Information:
Title
Implantation success rate of hydrogel spacer
Description
The success rate of hydrogel spacer implantation will be evaluated by the investigator for subjects.
Time Frame
during procedure
Title
Evaluation of device performance of hydrogel spacer
Description
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.
Time Frame
during procedure
Title
Injection volume of hydrogel spacer
Description
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.
Time Frame
during procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuquan Zhang, doctor
Phone
+86 13311360431
Email
zhangfuquan3@126.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junfang Yan, Doctor
Phone
+86 18611286276
Email
yanjunfang@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
22484226
Citation
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.
Results Reference
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PubMed Identifier
30237814
Citation
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.
Results Reference
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PubMed Identifier
31034570
Citation
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.
Results Reference
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Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space

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