Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Head and Neck Neoplasms

Disease Attributes

Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 3.5 watts. Device: AuroLase Therapy

Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 4.5 watts. Device: AuroLase Therapy

Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 5.0 watts. Device: AuroLase Therapy

Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions

AuroLase Therapy

This is an open-label, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the treatment of patients with refractory and/or recurrent tumors of the head and neck. Three (3) treatment groups of five (5) patients each will be enrolled and observed for six (6) months following treatment. Each group will receive a single dose of AuroShell(TM) particles followed by one or more interstitial illuminations with an 808nm laser. Particle dose and laser power may be increased in each dosing group.

Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck

A Pilot Study of AuroLase(tm) Therapy in Patients With Refractory and/or Recurrent Tumors of the Head and Neck

Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion

Nanospectra Biosciences, Inc.

If a subject experienced more than one event, the subject is only counted once for the most severe event. If a subject experience more than one event in an system class, the subject is only counted once.

All adverse events are being reported regardless of relation to study treatment.

Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.

AuroShell-3.5

Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.

AuroShell-4.5

Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.

AuroShell-5.0

Total

Age, Categorical

Gender

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Robin Dickson

Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration

Response in Targeted Tumors.

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Airway Obstruction

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.

Glenn Goodrich, PhD

This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy in the treatment of subjects with primary and/or metastatic tumors of the lung where there is airway obstruction. In this study patients will be given a systemic IV infusion of particles and a subsequent escalating dose of laser radiation delivered by optical fiber via bronchoscopy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck	NCT00848042	Head and Neck C...	AuroLase Therap...	18 Years - 130 Years	Nanospectra Biosciences, Inc.
Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors	NCT01679470	Primary or Meta...	AuroLase Therap...	18 Years -	Nanospectra Biosciences, Inc.
Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors	NCT01679470	Primary or Meta...	AuroLase Therap...	18 Years -	Nanospectra Biosciences, Inc.
Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck	NCT00848042	Head and Neck C...	AuroLase Therap...	18 Years - 130 Years	Nanospectra Biosciences, Inc.

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