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Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients (PDT)

Primary Purpose

Nonmelanoma Skin Cancers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
have Levulan Kerastick (aminolevulinic acid) solution
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonmelanoma Skin Cancers

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient has been the recipient of any solid organ transplant.
  2. Active immunosuppression for at least 5 years
  3. History of at least one NMSC
  4. Subject is willing to sign an informed consent to participate in this study.

Exclusion Criteria:

  1. Patient is not appropriate candidate for treatment or research trial per treating physician
  2. Patient has a mental health condition that makes them unable to participate in this research trial, per PI judgment.
  3. Patient is on additional immunosuppression for diagnosis unrelated to organ transplant -

Sites / Locations

  • Inova Melanoma Na Skin Oncology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered

Outcomes

Primary Outcome Measures

Number of non melanoma skin cancers in organ transplant recipients

Secondary Outcome Measures

Reduction of actinic keratosis damage/epidermal dysplasia in organ transplant recipients as assessed by physician and graded per actinic damage scale

Full Information

First Posted
March 21, 2016
Last Updated
October 4, 2021
Sponsor
Inova Health Care Services
Collaborators
DUSA Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02751151
Brief Title
Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients
Acronym
PDT
Official Title
Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
Collaborators
DUSA Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will draw patients from the Transplant Dermatology specialty clinic, where the investigators see organ transplant recipients (OTR) for regular screening and serve as a regional referral center for this population. Enrollment will be limited to 20 patients. Inclusion criteria are organ transplant recipients status, active immunosuppression for at least 5 years, and history of at least one NMSC.
Detailed Description
Patients will receive Levulan Kerastick (aminolevulinic acid) to the face and/or scalp (if both are needed, treated separately on back to back days); incubation: 2.5 hours and blue light photodynamic therapy utilizing the DUSA BLU-U device; illumination: 1000 seconds (16 min, 40 secs); administered quarterly for 3 years. Patients who change systemic immunosuppression regimens or add or increase systemic chemoprevention while in the study will be excluded from the overall analysis. The patients will be evaluated by the principal investigator every 3 months, prior to photodynamic therapy (PDT) administration. Primary endpoints include: development of non melanoma skin cancers (NMSC) lesions and assessment of actinic damage score. The primary endpoint will be development of new skin cancers at 3 years, based on comparison to rate at baseline from previous (x) year(s) using absolute slope value for number prior to treatment vs. number after treatment. The patients will serve as their own controls and the investigators will analyze the delta in development of non melanoma skin cancers and actinic damage score pre- and post- treatment. Additionally, an actinic damage score will be assigned based on the number of actinic keratosis on initial evaluation. At each 3 month follow up visit, the actinic damage score will be reassessed. The investigators will be able to secondarily analyze the delta in the actinic damage score on treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonmelanoma Skin Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered
Intervention Type
Other
Intervention Name(s)
have Levulan Kerastick (aminolevulinic acid) solution
Intervention Description
Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered
Primary Outcome Measure Information:
Title
Number of non melanoma skin cancers in organ transplant recipients
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Reduction of actinic keratosis damage/epidermal dysplasia in organ transplant recipients as assessed by physician and graded per actinic damage scale
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient has been the recipient of any solid organ transplant. Active immunosuppression for at least 5 years History of at least one NMSC Subject is willing to sign an informed consent to participate in this study. Exclusion Criteria: Patient is not appropriate candidate for treatment or research trial per treating physician Patient has a mental health condition that makes them unable to participate in this research trial, per PI judgment. Patient is on additional immunosuppression for diagnosis unrelated to organ transplant -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer DeSimone, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Melanoma Na Skin Oncology Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients

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