Trial Search Results

A Multi-Center Trial of the ProLung Testâ„¢

The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.

There are three Specific Aims of this study:

1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.

2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.

3. Assess the safety and tolerability of the ProLung Test procedures.

Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Fresh Medical Laboratories

Collaborator: Medical University of South Carolina

Stanford Investigator(s):

Eligibility


Inclusion Criteria:

Subjects who meet all of the following criteria may be enrolled in this Study:

   1. Subject is male or female, age 18 or older.

   2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or
   lesions suspicious for lung cancer.

   3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the
   largest nodule or lesion dimension identified from CT imaging.

   4. Subject meets one or more of the following conditions:

      - indicated for a tissue biopsy

      - indicated for surgical resection of the lung

   5. Subject must be able to receive a ProLung Test

      - within 60 days of abnormal CT (Inclusion Criterion 2 & 3)

      - within 60 days prior to the tissue biopsy or surgical resection (Inclusion
      Criterion 4).

   6. Subject is capable of understanding and agreeing to fulfill the requirements of this
   Protocol.

   7. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").

Exclusion Criteria

The following criteria will disqualify a subject from enrollment into this Study:

   1. Subject has an implanted electronic device in the chest.

   2. Subject receiving therapy for suspected chest infection such as fungal infection or
   tuberculosis.

   3. Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or
   any cancer in which the Principal Investigator does not suspect metastatic disease to
   the lung, who has 2 or more suspicious pulmonary nodules.

   4. Subject has received an invasive medical or surgical procedure within the thoracic
   cavity within 30 days prior to the ProLung Test or within the previous 14 days for a
   bronchoscopic procedure.

   5. Subject presents with an anomalous physical or anatomical condition that precludes
   ProLung Test measurement.

   6. Subject will have undergone unusually strenuous exercise within 24 hours.

   7. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced
   heart failure, or a recent myocardial infarction, or other medical condition such as
   severe morbid obesity that in the judgment of the Principal Investigator would make
   him/her unsuitable for the Study.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting