Computed Tomography (CT) Perfusion Imaging of Lung Cancer

Carcinoma, Non Small Cell Lung Clinical Trial

Official title:

CTP (Computed Tomography Perfusion) Imaging of Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00905801
• Other study ID #: 08-149
• Status: Terminated
• Phase: N/A
• First received: May 15, 2009
• Last updated: October 19, 2015
• Start date: June 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Other:
• CT 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).

Locations

Country	Name	City	State
United States	Hillman Cancer Center: University of Pittsburgh Cancer Institute / UPMC Department of Radiology	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute - Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No