Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer at 50 adult patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen

Criteria

Inclusion Criteria:

• ≥ 18 years

• Computertomography - morphologically locally - advanced gastric cancer (Classification of Malignant Tumours (TNM): size or direct extent of the primary tumor > 3 or degree of spread to regional lymph nodes positive) without distant metastases (except peritoneum)

• Histologically confirmed adenocarcinoma of the stomach

• Karnofsky Index > 70

Exclusion Criteria:

• Patients who are considered inoperable because of a reduced general condition:

• Congestive heart failure (New York Heart Association (NYHA) Functional Classification III / IV),

• Severe coronary heart disease, non-treatable arrhythmia or non-adjustable hypertension,

• Severe asthma suffering (Chronic obstructive pulmonary disease)

• Distant metastases except peritoneum

• Patients with a contraindication related to the present study

• Allergy or intolerance to the study drug or a substance with chemical similarity to the study medication.

• Lack of capacity to consent

• Participation in another interventional therapy studies at intervals of 30 days

• Contraindication to taking the prescribed study medication the physician's discretion

• Pregnancy/ Breastfeeding

• Women in childbearing age who refuse:

• Simultaneously apply two appropriate contraceptive measures or maintain a full hetero-sexual abstinence at least 28 days prior to the study and for at least 28 days after administration of study medication

• To stop breast-feeding during the study and through 6 months after the end of study

• Men who refuse:

• To use a latex condom during any sexual contact with childbearing women during the study and at least 28 days after completion of study, even if they are successful vasectomy.

• - Sperm donor to make up at least 28 days after completion of study.-