GINGA trial

JRCT ID: jRCTs031240345

Registered date:19/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: varian, fallopian tube and peritoneal cancer
• Date of first enrollment: 30/09/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

(1) Administration of study drug
Aminolevulinic acid hydrochloride is dissolved at 20 mg/kg in water and administered orally 3 hours (3 to 4 hours) before anesthesia.
(2) Specimen collection (before and during tumor debulking surgery or exploratory laparotomy).
Use commonly used medical equipment when performing tumor reduction surgery or exploratory laparotomy. Then, a general purpose light source that can switch between white light and excitation light is used.
Biopsy tissue specimens are collected using the method described below after the start of normal tumor reduction surgery or exploratory laparotomy and when the required area can be observed. In addition, the collection procedure will be videotaped and reviewed during the research period or after the study if necessary.
1) Biopsy tissue specimens will be collected in three patterns A to C below.
Basically, pattern A is collected, then pattern B is collected, and then pattern C is collected, but this is not limited to this. The order in which the light sources are observed does not matter. In addition, multiple samples should be collected as much as possible.
Pattern A: Blue test positive (+), white test negative (-)
Pattern B: Blue test negative (-), white test positive (+)
Pattern C: Blue test positive (+), white test positive (+)
2) For each sample collected, record the test results under a blue light source and under a white light source and the sampled area.
3) After observation, collect 2 specimens with both negative blue and white test as biopsies for the negative tissue specimens, one from the left paracolic gutter peritoneum (area d) and one from other areas. If collecting a tissue sample using biopsy forceps is judged to pose a high risk to the patient, the sample will not be collected.
(3) Specimen collection (before wound closure after tumor reduction surgery)
Biopsy tissue specimens will be collected before wound closure after tumor reduction surgery. It should not be performed before wound closure after exploratory laparotomy. Observe using a general-purpose light source that can switch between white light and excitation light. Collect up to 5 specimens with blue test positive and white test negative from all areas within the abdominal cavity. Record the information on the sample collected and the area where it was collected. If collecting a biopsy tissue sample using biopsy forceps is judged to pose a high risk to the patient, the sample will not be collected. Furthermore, the order in which the light sources are observed does not matter.

Outcome(s)

Primary Outcome

Sensitivity when performing photodynamic diagnosis on biopsy tissue specimens (by observation under blue light source and white light source)
Sensitivity: 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

1) 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.
2) Positive predictive value of photodynamic diagnosis for biopsy specimens collected from patients who have completed cytoreductive surgery (under blue light source)
3) Percentage of patients with malignant biopsy specimens with blue test a positive and a negative white test.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: TABATA TSUTOMU
• Source(s) of Monetary Support: SBI Pharmaceuticals Co., Ltd.