Status:
COMPLETED
Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Shanghai Reunion Biotech Co.,Ltd.
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05369221
Start Date
April 25 2022
End Date
October 10 2023
Last Update
November 13 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China