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Computed Tomography (CT) Perfusion Imaging of Lung Cancer

Primary Purpose

Carcinoma, Non Small Cell Lung

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT Perfusion
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Non Small Cell Lung focused on measuring Non small cell lung cancer, NSCLC, CTP, Perfusion, Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hillman Cancer Center: University of Pittsburgh Cancer Institute / UPMC Department of Radiology
  • University of Pittsburgh Cancer Institute - Hillman Cancer Center
  • University of Pittsburgh Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm A CT Perfusion

Arm B CT Perfusion

Arm 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.

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.

Outcomes

Primary Outcome Measures

Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.

Secondary Outcome Measures

Reproducibility of tumor blood flow estimates derived by CT.
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).
Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.

Full Information

First Posted
May 15, 2009
Last Updated
October 19, 2015
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00905801
Brief Title
Computed Tomography (CT) Perfusion Imaging of Lung Cancer
Official Title
CTP (Computed Tomography Perfusion) Imaging of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Co-PI left institution, PI not pursuing
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Reproducibility of tumor blood flow estimates derived by CT. 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). Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non Small Cell Lung
Keywords
Non small cell lung cancer, NSCLC, CTP, Perfusion, Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A CT Perfusion
Arm Type
Other
Arm 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.
Arm Title
Arm B CT Perfusion
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
CT Perfusion
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A. Socinski, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillman Cancer Center: University of Pittsburgh Cancer Institute / UPMC Department of Radiology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Pittsburgh Cancer Institute - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

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Computed Tomography (CT) Perfusion Imaging of Lung Cancer

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