Computed Tomography (CT) Perfusion Imaging of Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00905801
First received: May 15, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Carcinoma, Non Small Cell Lung
Other: CT Perfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CTP (Computed Tomography Perfusion) Imaging of Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique. [ Time Frame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reproducibility of tumor blood flow estimates derived by CT. [ Time Frame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later. ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later. ] [ Designated as safety issue: No ]
  • Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations. [ Time Frame: Data collected during one required study visit, and optional second study visit ~6-8 weeks later; and during SOC follow-up for survival. ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: June 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A CT Perfusion

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.

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).
Arm B CT Perfusion

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.

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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905801

Locations
United States, Pennsylvania
Hillman Cancer Center: University of Pittsburgh Cancer Institute / UPMC Department of Radiology
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Cancer Institute - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Mark A. Socinski, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00905801     History of Changes
Other Study ID Numbers: 08-149
Study First Received: May 15, 2009
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Non small cell lung cancer
NSCLC
CTP
Perfusion
Imaging

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014