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

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ClinicalTrials.gov Identifier: NCT02840331
Recruitment Status : Unknown
Verified October 2017 by Prof. Dr. Stefan Beckert, University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : July 21, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Stefan Beckert, University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Drug: St. John's Wort Device: Photodynamic diagnostic and therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Peritoneal metastases in terms of tumor size [centimeter, cm] [ Time Frame: Day 1 (day of surgery) ]
    Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of tumor size [cm]

  2. Peritoneal metastases in terms of number [n] [ Time Frame: Day 1 (day of surgery) ]
    Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of number [n]

  3. Peritoneal metastases in terms of location [ Time Frame: Day 1 (day of surgery) ]
    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]


Secondary Outcome Measures :
  1. Hypericin level [ Time Frame: Day 1 (day of surgery) ]
    Hypericin levels in the peritoneum and serum the day of surgery

  2. Histological evidence of apoptosis [ Time Frame: Day 1 (day of surgery) ]
    Histological evidence of apoptosis in peritoneal metastasis after photodynamic therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840331


Contacts
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Contact: Stefan Beckert, Prof. Dr. +49-(0)7071-29-81222 stefan.beckert@med.uni-tuebingen.de
Contact: Alfred Königsrainer, Prof. Dr. +49-(0)7071-29-81222 alfred.koenigsrainer@med.uni-tuebingen.de

Locations
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Germany
University Department of General, Visceral and Transplant Surgery Recruiting
Tübingen, Baden.Württemberg, Germany, 72076
Contact: Stefan Beckert, Prof. Dr.    +49-(0)7071-29-86619    stefan.beckert@med.uni-tuebingen.de   
Contact: Alfred Königsrainer, Prof. Dr.    +49-(0)7071-29-86619    alfred.koenigsrainer@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Stefan Beckert, Prof. Dr. University Department of General, Visceral and Transplant Surgery
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Responsible Party: Prof. Dr. Stefan Beckert, Chief consultant, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02840331    
Other Study ID Numbers: Hypericin-PDT
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Stefan Beckert, University Hospital Tuebingen:
Gastric carcinoma
Peritoneal carcinomatosis
Photodynamic diagnosis
Photodynamic therapy
St. John's Wort
Peritoneal metastasis
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases