Clinical trial NCT00905801: Computed Tomography (CT) Perfusion Imaging of Lung Cancer
Official title: CTP (Computed Tomography Perfusion) Imaging of Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Non Small Cell Lung
Keywords: Non small cell lung cancer
NSCLC
CTP
Perfusion
Imaging
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.
timeFrame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later.
Secondary outcomes:
measure: Reproducibility of tumor blood flow estimates derived by CT.
timeFrame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later.
measure: 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).
timeFrame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later.
measure: Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.
timeFrame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later; and during SOC follow-up for survival.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Hillman Cancer Center: University of Pittsburgh Cancer Institute / UPMC Department of Radiology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute - Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mark A. Socinski, MD
role: PRINCIPAL_INVESTIGATOR
References: