Computed Tomography (CT) Perfusion Imaging of Lung Cancer

University of Pittsburgh

Status: Terminated

Conditions: Carcinoma, Non Small Cell Lung

Treatments: Other: CT Perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00905801

08-149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Arm A CT Perfusion

Other group

Description:

Arm A Procedure On the first required study visit, subject will undergo one SOC CT scan followed by the research component: * CTP imaging: Single bed position CTP examination, which includes injection of 30 cc of contrast agent, over the predetermined lesion from clinical scan * Subject will stand up and walk around, and then lay back down * CT Perfusion imaging: Second single bed position CTP examination, which includes injection of 30 cc of contrast agent, over the predetermined lesion from their clinical scan Procedures will be repeated at optional second study visit \~6-8 weeks later.

Treatment:

Other: CT Perfusion

Arm B CT Perfusion

Other group

Description:

Arm B Procedure On the first required study visit, subject will undergo one SOC CT scan followed by the research component: - CT Perfusion imaging: Single bed position CTP examination, which includes injection of 30 cc of contrast agent, over the predetermined lesion from clinical scan Procedures will be repeated at optional second study visit \~6-8 weeks later.

Treatment:

Other: CT Perfusion