Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis

NCT02840331 | Unknown Phase 3

• 1 other identifier: Hypericin-PDT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Carcinomatosis

Keywords

Gastric carcinoma; Peritoneal carcinomatosis; Photodynamic diagnosis; Photodynamic therapy; St. John's Wort; Peritoneal metastasis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Hypericin level

  Day 1 (day of surgery)

• Histological evidence of apoptosis

  Day 1 (day of surgery)

Study Arms (1)

St. John's Wort & PDD, PDT

EXPERIMENTAL

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; Device: Photodynamic diagnostic and therapy

Interventions

St. John's Wort DRUG

Single oral doses (900 milligram) 2-4 hours before laparoscopy

Also known as: Laif 900

St. John's Wort & PDD, PDT

Photodynamic diagnostic and therapy DEVICE

Intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes

St. John's Wort & PDD, PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Department of General, Visceral and Transplant Surgery

Tübingen, Baden.Württemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Peritoneal Neoplasms; Stomach Neoplasms

Interventions

Hypericum extract LI 160; LAIF 900; Therapeutics

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Stefan Beckert, Prof. Dr.

  University Department of General, Visceral and Transplant Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Beckert, Prof. Dr.

CONTACT

+49-(0)7071-29-81222; stefan.beckert@med.uni-tuebingen.de

Alfred Königsrainer, Prof. Dr.

CONTACT

+49-(0)7071-29-81222; alfred.koenigsrainer@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief consultant

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 21, 2016
• Study Start: July 31, 2017
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)