Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis (Hypericin-PDT)

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.

Study Overview

• Status: Unknown
• Conditions: Peritoneal Carcinomatosis
• Intervention / Treatment: Drug: St. John's Wort; Device: Photodynamic diagnostic and therapy

Detailed Description

Hypericin-PDT study is an examination of patients with gastric cancer. The peritoneal carcinosis (PC) of the adult represents the final stage of an advanced tumor and was treated in the past, usually by means of palliative chemotherapy. An improvement in survival for patients with PC could be further improved through the use of maximum cytoreductive surgery (CRS) can be achieved with radical removal of the entire tumor mass and the combination of CRS and intraperitoneal hyperthermic chemotherapy (HIPEC) event-free survival and overall survival. A cure of patients is achieved only in the rarest cases. An essential problem in the treatment of peritoneal carcinomatosis is that can only be poorly differentiated from surrounding tissue due to their location, the tumors often not well recognized because of their size or. This results to differ (as scar tissue) for the surgeon the difficulty between eigentlichem tumor tissue and surrounding tissue.

Through the use of innovative diagnostic and therapeutic options (for example, photodynamic diagnosis (PDD) and therapy (PDT)) above mentioned problems can be improved. In photodynamic diagnosis contrast between tumor and surrounding healthy tissue is improved by an interaction of photodynamic active substance with light of a particular wavelength. The PDT is based on a topical or systemic administration of a photosensitizer (here hypericin), which is irradiated with light of a suitable wavelength and in the presence of oxygen oxygen radicals (with the consequence of a direct cytotoxicity of the tumor cells leading) forms.

The study will be carried out in the Department of General, Visceral and Transplantation Surgery Tübingen at 50 adult patients. The study proposed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Baden.Württemberg
    • Tübingen, Baden.Württemberg, Germany, 72076
      • Recruiting
      • University Department of General, Visceral and Transplant Surgery
      • Contact: Stefan Beckert, Prof. Dr.; Phone Number: +49-(0)7071-29-86619; Email: stefan.beckert@med.uni-tuebingen.de
      • Contact: Alfred Königsrainer, Prof. Dr.; Phone Number: +49-(0)7071-29-86619; Email: alfred.koenigsrainer@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: St. John's Wort & PDD, PDT; St. John's Wort 900 milligram once oral preoperative & intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes	Drug: St. John's Wort; Single oral doses (900 milligram) 2-4 hours before laparoscopy; Other Names: Laif 900; Device: Photodynamic diagnostic and therapy; Intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peritoneal metastases in terms of tumor size [centimeter, cm]	Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of tumor size [cm]	Day 1 (day of surgery)
Peritoneal metastases in terms of number [n]	Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of number [n]	Day 1 (day of surgery)
Peritoneal metastases in terms of location	Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of location [central, right upper, epigastrium, left upper, , left flank, left lower, pelvis, riht lower, right flank, upper jejunum, lower jejunum, upper ileum, lower illeum]	Day 1 (day of surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypericin level	Hypericin levels in the peritoneum and serum the day of surgery	Day 1 (day of surgery)
Histological evidence of apoptosis	Histological evidence of apoptosis in peritoneal metastasis after photodynamic therapy	Day 1 (day of surgery)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Stefan Beckert, Prof. Dr., University Department of General, Visceral and Transplant Surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Photodynamic therapy; Peritoneal metastasis; Peritoneal carcinomatosis; St. John's Wort; Gastric carcinoma; Photodynamic diagnosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Abdominal Neoplasms; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: Hypericin-PDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No