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Dynamic Perfusion Computed Tomography Changes After Stereotactic Body Radiation Therapy for Localized Non-small Cell Lung Cancer

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.

Phase

N/A

Inclusion and Exclusion 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

  • 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

Sites

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