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Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs


N/A
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms, Lung Transplantation

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Trial Information

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs


The primary aim of this study is to develop the criteria to differentiate healthy versus
diseased tissue in patient with discrete lung lesions or to characterize acute lung
rejection in patients with transplanted lungs. Once these criteria have been defined, the
diagnostic parameters and the reproducibility of pCLE will be assessed.


Inclusion Criteria:



- Male or female > 18 years of age

- Willing and able to comply with study procedures and provide written informed consent
to participate in the study

- Indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic
bronchoscopy

- Newly discovered &/or prior discovered non classified nodules, hard to define based
on CT scan

- Purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary
nodule or multiple lesions

- All lesion locations are acceptable

- Any patient undergoing clinically indicated bronchoscopies after lung transplantation

- Patients post transplant showing clinical signs of acute rejection >3 weeks; < 1 year

- Patient with single or double lung transplant

Exclusion Criteria:

- Contraindication to short-acting anesthetic agents;

- Contraindications to transbronchial biopsy

- Bleeding diathesis;

- A pacemaker/defibrillator;

- A diagnosis by other means (sputum cytology, microbiology).

- Unwilling To Consent

- Unable To Safely Tolerate A Bronchoscopic Procedure

- Unwilling To Comply With Surveillance Bronchoscopy Follow Up

- Chronic Rejection

- Fungal Disease

- Ax Histological Assessment Or Incomplete Biopsy Procedure Should Be Considered As A
Screen Failure

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Development of criteria for the characterization of discrete lung lesions and for characterization of acute lung rejection in lung transplant.

Outcome Time Frame:

Up to 12 months

Safety Issue:

No

Principal Investigator

Cesar Keller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic - Jacksonville, FL

Authority:

United States: Food and Drug Administration

Study ID:

MKT_2012_lung_01

NCT ID:

NCT01793246

Start Date:

February 2013

Completion Date:

December 2013

Related Keywords:

  • Lung Neoplasms
  • Lung Transplantation
  • lung cancer
  • lung neoplasms
  • lung transplant
  • Neoplasms
  • Lung Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Mayo ClinicJacksonville, Florida  32224
Ohio State UniversityColumbus, Ohio  43210
University of ChicagoChicago, Illinois  60637