Carcinoma, Non Small Cell LungNCT00905801
Computed Tomography (CT) Perfusion Imaging of Lung Cancer
A study testing CT Perfusion in people with Carcinoma, Non Small Cell Lung, run by University of Pittsburgh at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non Small Cell Lung
- What is being tested?
- CT Perfusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Hillman Cancer Center: University of Pittsburgh Cancer Institute / UPMC Department of Radiology
Pittsburgh, Pennsylvania, 15232
University of Pittsburgh Cancer Institute - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: CTP (Computed Tomography Perfusion) Imaging of Lung Cancer
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.
Read the detailed description
Drug/Device Information
- Contrast
30 cc bolus of a low osmolar, iodinated CT contrast agent, which is FDA approved and used in the clinical CT Imaging procedure.
- 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
- Primary Endpoint
- Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.
- 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.
- Conditions
- Carcinoma, Non Small Cell Lung
- Being tested
- CT Perfusion
- Keywords
- Non small cell lung cancer, NSCLC, CTP, Perfusion, Imaging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT PerfusionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm A CT Perfusion | Other | 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. Receives: Other: CT Perfusion |
| Arm B CT Perfusion | Other | 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. Receives: Other: CT Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.
Measured: Data collected during one required study visit, and optional second study visit ~6-8 weeks later.
Secondary outcomes (3)
Reproducibility of tumor blood flow estimates derived by CT.
Measured: Data collected during one required study visit, and optional second study visit ~6-8 weeks later.
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).
Measured: Data collected during one required study visit, and optional second study visit ~6-8 weeks later.
Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.
Measured: Data collected during one required study visit, and optional second study visit ~6-8 weeks later; and during SOC follow-up for survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Co-PI left institution, PI not pursuing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non Small Cell LungStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A. Socinski, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905801
- Sponsor's protocol ID
- 08-149
- Status last verified
- Oct 2015
- First submitted
- 15 May 2009
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTP (Computed Tomography Perfusion) Imaging of Lung Cancer
- ClinicalTrials.gov ID
- NCT00905801
- Acronym / sponsor ID
- 08-149
- Conditions
- Carcinoma, Non Small Cell Lung
- Keywords
- Non small cell lung cancer, NSCLC, CTP, Perfusion, Imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Co-PI left institution, PI not pursuing
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Contrast
30 cc bolus of a low osmolar, iodinated CT contrast agent, which is FDA approved and used in the clinical CT Imaging procedure.
- 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
- Primary Endpoint
- Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A CT Perfusion | Other | Other: CT PerfusionArm 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 CT Perfusion | Other | Other: CT PerfusionArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT PerfusionSubjects 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). | Other | Arm A CT Perfusion, Arm B CT Perfusion |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study was stopped early (reason given: Co-PI left institution, PI not pursuing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Socinski, MD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Perfusion in people with Carcinoma, Non Small Cell Lung, run by University of Pittsburgh at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Co-PI left institution, PI not pursuing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.