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To evaluate a prospective, multicenter, randomized, parallel controlled, superior clinical trial of disposable absorbable isolation hydrogel for reducing rectal radiation dose in radiotherapy of cervical cancer

To evaluate a prospective, multicenter, randomized, parallel controlled, superior clinical trial of disposable absorbable isolation hydrogel for reducing rectal radiation dose in radiotherapy of cervical cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089953
Enrollment
Unknown
Registered
2024-09-20
Start date
2024-04-16
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical carcinoma

Interventions

B:SpaceRTC implantation

Sponsors

SCIENCES ZHEJIANG CANCER HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed cervical cancer through pathological examination, plan to use intensity modulated radiotherapy (IMRT) combined with three-dimensional close range radiotherapy for root canal treatment Patients undergoing therapeutic radiotherapy and concurrent chemotherapy; 2. Karst score = 70 points; 3. Female patients; Age = 18 years old, = 75 years old; 4. There are no metal implants in the pelvic cavity or joints, and they can withstand MRI examination; 5. No contraindications for CT scanning; 6. Able to understand the purpose of the experiment, voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previously received pelvic radiation therapy; 2. Previously received treatment for the target tumor (surgery, chemotherapy, immunotherapy, targeted drugs); 3. History of other malignant tumors within the past 5 years (excluding malignant tumors that have undergone radical surgery, such as complete resection)Basal cell carcinoma, in situ carcinoma, etc; 4. According to the researcher's judgment, the subject has contraindications to radiotherapy; 5. There is an infection at the injection site, or there is active inflammation or infection in the surrounding tissues or organs that may affect the injection site Injection safety; 6. According to the researcher's judgment, the tumor invades the injection site and may affect the injection process and injection safety; 7. Known to be allergic to the ingredients of the test product, known to be allergic to iodinated contrast agents, known to have a history of severe allergic reactions or allergies History of sexual shock; 8. Untreated hyperthyroidism; 9. Have a history of inflammatory bowel disease (such as ulcerative colitis, Crohn's disease); 10. Existence of active hemorrhagic disease (excluding vaginal bleeding related to the target tumor), or platelet count less than50 × 10^9/L; 11. Individuals with severe mental illness, cognitive impairment, and cognitive impairment; 12. Those who have participated in clinical trials of other medical devices or drugs within one month before signing the informed consent form; 13. Pregnant women, lactating women, or those who plan to conceive during the study period; 14. Other circumstances in which the researcher determines that the subject is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Accumulated dose of rectal D2cc for close range radiotherapy;

Secondary

MeasureTime frame
Evaluation of cumulative dose for rectal D0.1cc, D5cc, and efficacy of sigmoid colon/small intestine/bladder D0.1cc, D2cc, and D5cc in close range radiotherapy;Success rate of hydrogel implantation;Stability of hydrogel;Image quality evaluation of hydrogel imaging;QLQ-C30 rating;QLQ-CX24 rating;Equipment performance evaluation;

Countries

China

Contacts

Public ContactXiang Zhang

SCIENCES ZHEJIANG CANCER HOSPITAL

zhangxiang@zjcc.org.cn+86 159 8810 9696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026