A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03133650|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : May 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophagogastric Cancer Moderate to Severe Dysphagia||Drug: WST 11-mediated VTP therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Vascular-Targeted Photodynamic Therapy in Esophagogastric Cancer Patients With Moderate to Severe Dysphagia|
|Actual Study Start Date :||April 26, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Vascular-targeted photodynamic therapy (VTP) using WST11
Participants will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes, during an endoscopy procedure, followed by immediate laser light application.
Drug: WST 11-mediated VTP therapy
Administration of WST11 in conjunction with endoscopic illumination at 753 nm emitted by a diode laser and administered to the participant by optical fibre catheters (cylindrical light diffusers) and a standard upper GI endoscope.
- Maximum tolerated laser fluence rate [ Time Frame: 60 days ]The maximally tolerated laser light fluence rate (mW/cm) of light exposure for VTP of malignant obstruction due to esophagogastric cancer will be measured by examining 6 fluence rates beginning with a fluence rate of 150 nW/cm, then increasing by 50mW/cm, up to a maximum of 400 mW/cm (150, 200, 250 300, 350, 400).
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): NCT03133650
|Contact: Hans Gerdes, MDemail@example.com|
|Contact: David Kelsen, MD||646-888-4179|
|United States, New York|
|Memorial Sloan - Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Hans Gerdes, MD 212-639-7108|
|Weizmann Institute of Science||Active, not recruiting|
|Principal Investigator:||Hans Gerdes, MD||Memorial Sloan Kettering Cancer Center|