GINGA trial

Recruiting

• Conditions: varian, fallopian tube and peritoneal cancer

• Registration Number: jRCTs031240345

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-19
• Study Start: 2024-10-05
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. 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.

2. Patients who understand the contents of the informed consent documents and are able to give written consent of their own free will.
3. Patients aged 18 to under 85 (at the time of signing the consent form).
4. Patients with an ECOG Performance Status (ECOG PS) of 0 to 1 determined at the time of enrollment.
5. Patients who are able to comply with study protocol requirements, such as visit schedule.

Exclusion Criteria

1. Patients with a history or complications of any of the following reasons ;

• Myocardial infarction
• Congestive heart failure
• Angina requiring treatment
• Arrhythmia requiring treatment

2. Patients with the following serious complications: intestinal pneumonia, pulmonary fibrosis, poorly controlled hypertension, poorly controlled diabetes, etc.
3. Patients with serious infectious disease (including active tuberculosis).
4. Patients with active multiple cancers.
5. 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.

6. Systolic blood pressure is 90 mmHg or less, or diastolic blood pressure is 50 mmHg or less in the screening test.
7. Patients who have experienced hypotension or decreased blood pressure when aminolevulinic acid hydrochloride was administered in the past.
8. Patients who are pregnant, breastfeeding, or may be pregnant.
9. Patients who do not intend to use contraception.
10. Patients with a history of hypersensitivity to aminolevulinic acid hydrochloride or porphyrin analogs.
11. Porphyria
12. Patients who have undergone cancer drug therapy or cancer resection within 21 days before surgery.
13. Patients with a history of abdominal radiotherapy.
14. 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.
15. Patients judged to be unsuitable by the research physician.

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Other diagnostic accuracy (specificity, negative predictive value, positive predictive value when observed under blue light source and white light source)		Specificity: Among specimens diagnosed as non-malignant, the percentage of specimens collected with a negative blue test or negative white test after the start of cytoreductive surgery or exploratory laparotomy.; Negative predictive value: the percentage of specimens collected with a negative blue test or negative white test after starting cytoreductive surgery or exploratory laparotomy that are diagnosed as non-malignant among those.; Positive predictive value: the percentage of specimens collected that are positive blue or white test after the start of cytoreductive surgery or exploratory laparotomy that are diagnosed as pathologically malignant among the those.; *When calculating diagnostic accuracy under a blue light source, the result of the blue test positive is used, and when calculating the diagnostic accuracy under a white light source, the result of a positive white test is used.