Carcinoma, Non Small Cell Lung
Conditions
Keywords
Non small cell lung cancer, NSCLC, CTP, Perfusion, Imaging
Brief summary
This is an experimental study of the feasibility and efficacy of CT perfusion (CTP) imaging (CT blood flow measurements) in subjects with non-small cell lung cancer.
Detailed description
Drug/Device Information 1\) Contrast 30 cc bolus of a low osmolar, iodinated CT contrast agent, which is FDA approved and used in the clinical CT Imaging procedure. 2\) Scanner The 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI) is FDA approved for clinical CT imaging Research Design and Methods 1\) Primary Endpoint 1\. Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique. 2\) Secondary Endpoints 1. Reproducibility of tumor blood flow estimates derived by CT. 2. Assessment of the association between tumor vascularity responses after two cycles of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST). 3. Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.
Interventions
OTHERCT Perfusion
Subjects will be examined with a CTP Imaging protocol which comprises repeated CT-scans of the tumor over a period of 50 seconds following the injection of a 30cc bolus of an FDA-approved low osmolar, iodinated CT contrast agent using a 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI). One scan will be acquired every 3 seconds over a 50s period at 100 kV, and 100mA tube current. With this method, a 4cm long segment of the tumor can be analyzed, and 32 images of a slice thickness of 1.25 mm reconstructed simultaneously. Images will be evaluated using standard CT blood flow software (Perfusion 2, AW, GE Health Care, Milwaukee, WI).
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with any stage non-small cell lung cancer (NSCLC) who will undergo imaging with CT of the chest with intravenous contrast as standard of care. Other imaging tests will be performed as clinically indicated. * Patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy. Patients should not be receiving adjuvant or postoperative treatment but neoadjuvant treatment is allowed. * Histologically or cytologically proven NSCLC. * At least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm, according to Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be either proven to be malignant by biopsy or be considered malignant based on its evolution on previous imaging studies. A scan within 3-6 months prior to registration can be used as the baseline scan. * Age 18 years or older and ability to provide informed consent. * Subjects must use medically appropriate contraception if sexually active; women of childbearing potential must not be pregnant or breastfeeding * Subjects must have normal renal function to participate. Standard laboratory testing to evaluate renal function will be performed prior to administering IV contrast and will be available as standard of care. Renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 BSA, derived from the patients' serum creatinine concentration.
Exclusion criteria
* Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding; * Established allergy to iodine containing contrast media
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique. | Data collected during one required study visit, and optional second study visit ~6-8 weeks later. |
Secondary
| Measure | Time frame |
|---|---|
| Reproducibility of tumor blood flow estimates derived by CT. | Data collected during one required study visit, and optional second study visit ~6-8 weeks later. |
| Assessment of the association between tumor vascularity responses after two cycles of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST). | Data collected during one required study visit, and optional second study visit ~6-8 weeks later. |
| Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations. | Data collected during one required study visit, and optional second study visit ~6-8 weeks later; and during SOC follow-up for survival. |
Countries
United States
Outcome results
None listed