Clinical trial NCT03091816: Dynamic Perfusion Computed Tomography in Patients With Localized Non-small Cell Lung Cancer
Official title: Dynamic Perfusion Computed Tomography Changes After Stereotactic Body Radiation Therapy for Localized Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage IA Non-Small Cell Lung Carcinoma
Stage IB Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Stage IIB Non-Small Cell Lung Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Society of Thoracic Radiology
First posted: 2017-03-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with lung cancer who will undergo SBRT at USC hospitals and clinics.

Brief summary: This pilot clinical trial studies the changes in dynamic perfusion computed tomography images before, during, and after stereotactic body radiation therapy in patients with stage I-II non-small cell lung cancer that has not spread to other parts of the body. Diagnostic imaging procedures, such as dynamic perfusion computed tomography, measure blood flow through tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving dynamic perfusion computed tomography images before, during, and after stereotactic body radiation therapy may help better understand how radiation therapy works to stop tumor growth in patients with non-small cell lung cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To describe perfusion computed tomography (CT) parameters and their changes in non-small cell lung cancer (NSCLC) tumors prior to, during, 1 month after, and 3 months after stereotactic body radiation therapy (SBRT).

SECONDARY OBJECTIVES:

I. To correlate tumor perfusion parameters with clinical tumor response on follow up per standard of care.

TERTIARY OBJECTIVES:

I. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and circulating tumor cell (CTC) with clinical response rates and perfusion parameters.

OUTLINE:

Patients undergo dynamic perfusion computed tomography (DPCT) at baseline, during SBRT (after 2 of 3 fractions or 3 of 5 fractions), and then at 1 and 3 months post stereotactic body radiation therapy.

After completion of study, patients are followed up at 6, 12, 18, and 24 months.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven non-small cell lung cancer
* Minimum tumor dimension \>= 1 cm (preferably \>= 2 cm)
* No clinical evidence of nodal disease (N1-N3) as assessed by CT and/or positron emission tomography (PET)/CT
* Zubrod performance status 0-2
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

  * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    * Has not undergone a hysterectomy or bilateral oophorectomy; or
    * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* No prior radiation to the same area
* No concurrent chemotherapy
* Evaluated by radiation oncologist to be appropriate SBRT candidate and scheduled to undergo SBRT as part of their care
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients with tumors \< 1 cm
* Patients with nodal disease or distant metastatic disease
* Patients may not be receiving any other investigational agents
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients must not be pregnant
* Patients with allergies to iodinated contrast not amenable to pre-medication
* Patients who are not able to lie supine with arms raised, and cooperate with breathholding instructions

Primary outcomes:
measure: Change in blood flow (mL/min/100 g) as measured on perfusion CT
timeFrame: Baseline to up to 3 months post SBRT
measure: Change in blood volume (mL/100 g) as measured on perfusion CT
timeFrame: Baseline to up to 3 months post SBRT
measure: Change in mean transit time (seconds) as measured on perfusion CT
timeFrame: Baseline to up to 3 months post SBRT
measure: Change in permeability (mL/min/100 g) as measured on perfusion CT
timeFrame: Baseline to up to 3 months post SBRT
Secondary outcomes:
measure: Clinical tumor response assessed by CT scans as determined by Response Evaluation Criteria in Solid Tumors criteria version 1.1
timeFrame: Up to 24 months post SBRT
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Christopher Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: