Clinical trial NCT05369221: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterine Cervical Neoplasms
Keywords: Cervical Cancer
hydrogel spacer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Reunion Biotech Co.,Ltd.
First posted: 2022-05-11
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The cumulative D2cc dose for rectum during brachytherapy
timeFrame: 21 days post index procedure
Secondary outcomes:
measure: Implantation success rate of hydrogel spacer
timeFrame: during procedure
measure: Evaluation of device performance of hydrogel spacer
timeFrame: during procedure
measure: Injection volume of hydrogel spacer
timeFrame: during procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
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.
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.
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.