The role of aminolevulinic acid hydrochloride in fluorescence guided debulking surgery and exploratory laparoscopy for patients with ovarian, fallopian tube and peritoneal cancer.

未提供0 个研究点目标入组 20 人开始时间: 2024年10月5日最近更新: 2025年4月30日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 20
主要终点: Sensitivity when performing photodynamic diagnosis on biopsy tissue specimens

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 85age old not（—）
性别: Female

入选标准

•Patients scheduled for cytoreductive surgery or exploratory laparotomy for the following reasons ;
•Diagnosis or clinical suspicion of ovarian, fallopian tube or peritoneal cancer.
•Recurrence of ovarian, fallopian tube or peritoneal cancer.
•Patients with suspected ovarian, fallopian tube or peritoneal cancer based on MRI, PET or CT results up to 60 days before study drug administration.
•Patients who understand the contents of the informed consent documents and are able to give written consent of their own free will.
•Patients aged 18 to under 85 (at the time of signing the consent form).
•Patients with an ECOG Performance Status (ECOG PS) of 0 to 1 determined at the time of enrollment.
•Patients who are able to comply with study protocol requirements, such as visit schedule.

排除标准

•Patients with a history or complications of any of the following reasons ;
•Myocardial infarction
•Congestive heart failure
•Angina requiring treatment
•Arrhythmia requiring treatment
•Patients with the following serious complications: intestinal pneumonia, pulmonary fibrosis, poorly controlled hypertension, poorly controlled diabetes, etc.
•Patients with serious infectious disease (including active tuberculosis).
•Patients with active multiple cancers.
•Clinical test values meet the following criteria (values taken up to 28 days before the study drug administration date):
•Renal function: serum creatinine is more than 1.5 times the upper limit of the reference value.
•Liver function: AST is more than 3 times the upper limit of the reference value and ALT is more than 3 times the upper limit of that. Serum bilirubin is more than 1.5 times the upper limit of the reference value.
•Systolic blood pressure is 90 mmHg or less, or diastolic blood pressure is 50 mmHg or less in the screening test.
•Patients who have experienced hypotension or decreased blood pressure when aminolevulinic acid hydrochloride was administered in the past.
•Patients who are pregnant, breastfeeding, or may be pregnant.
•Patients who do not intend to use contraception.
•Patients with a history of hypersensitivity to aminolevulinic acid hydrochloride or porphyrin analogs.
•Porphyria
•Patients who have undergone cancer drug therapy or cancer resection within 21 days before surgery.
•Patients with a history of abdominal radiotherapy.
•Patients who have received unapproved or off-label drugs in other clinical trials within 90 days before the start of screening, or who are scheduled to participate in clinical trials or research during the study period.
•Patients judged to be unsuitable by the research physician.

结局指标

主要结局

Sensitivity when performing photodynamic diagnosis on biopsy tissue specimens

Among specimens diagnosed as malignant, the percentage of specimens collected with a positive blue or white test after the start of cytoreductive surgery or exploratory laparotomy.

次要结局

Other diagnostic accuracy (specificity, negative predictive value, positive predictive value when observed under blue light source and white light source)

研究者

发起方

未提供

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