The study of radiotherapy for gynecological tumors using lipiodol

Prospective study about the safety of radiotherapy for gynecologic tumors using ethyl ester of iodinated poppy-seed oil fatty acid - The study of radiotherapy for gynecological tumors using lipiodol

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs021190022

Enrollment

Registered

2020-02-20

Start date

2020-02-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Cervical cancer, Vaginal cancer Cervical cancer, Vaginal cancer

Interventions

Injection of lipiodol at 2-3 mm under the submucosa at two or three point around the tumor.

Lipiodol

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Cervical cancer, Vaginal cancer (2) Patients with indications for definitive radiotherapy (3) Age between 20 and 80 years old (4) ECOG performance status 0-2 (5) No prior abdominopelvic irradiation (6) It is possible to stop taking or do not intake any anticoagulant or antiplatelet (7) Patients with sufficient organ function - neutrophil count greater than 2,000/mm3 - hemoglobin greater than 8g/dL - platelets greater than 50,000/mm3 - albumin greater than 3.0 g/dL - total bilirubin lower than 2.0mg/dL - AST (GOT) and ALT (GPT) lower than 150 IU/L -serum creatinine lower than 1.2mg/dL (8) Patient must provide study-specific informed consent prior to study entry

Exclusion criteria

Exclusion criteria: (1) Severe comorbidities (such as heart failure, renal failure, hepatic failure, respiratory dysfunction, lymph duct obstruction, poorly controlled diabetes and poorly controlled hypertension) (2) Active thyroid disease (3) Pyrexia of 38 degrees centigrade or higher. (4) An allergy to iodine drugs (5) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. (6) Psychiatric comorbidities or problems hinders enrollment of the study (7) Attending physician believes the patient is not suitable for the study

Design outcomes

Primary

Measure	Time frame
Evaluation of safety by injection of ethyl ester of iodinated poppy-seed oil fatty acid.	—

Secondary

Measure	Time frame
Evaluation of retention period by injecting ethyl ester of iodinated poppy-seed oil fatty acid. Evaluated of contouring by injection of ethyl ester of iodinated poppy-seed oil fatty acid.	—

Contacts

Public ContactRei Umezawa

Tohoku University Graduate School of Medicine

reirei513@hotmail.com+81-22-717-7312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026