[F-18] FLT PET in Measuring Tumor Response in Patients with Solid Tumors or Hematopoietic Cancer

Status: Active

Description

This pilot clinical trial studies fluorothymidine F-18 ([F-18] FLT) positron emission tomography (PET) in measuring tumor response in patients with solid tumors or a cancer of the blood or bone marrow, such as leukemia or lymphoma (hematopoietic cancer). Diagnostic procedures, such as fluorothymidine F-18 positron emission tomography, may help measure a patient's response to earlier treatment. Comparing results of diagnostic procedures done during or after chemotherapy may help doctors predict patient's response to treatment and help plan the best treatment.

Eligibility Criteria

Inclusion Criteria

  • Prior histologic diagnosis of cancer or awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging; this includes solid tumors as well as hematologic malignancies
  • Patients who have received no prior therapy are eligible, as well as those who have received prior treatment
  • Patients must be able to lie still for the tests; their girth and weight must be suitable to enter the gantry, which varies per tomograph
  • Women of child bearing potential must not be pregnant or breastfeeding; a negative serum pregnancy test must be obtained in women with child bearing potential within 7 days of the first PET scan; men and women with reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) on study entry and for the duration of study participation; on the day of the scan the staff will verify and record that the patient has not had unprotected intercourse and does not think that she is pregnant; a repeat serum pregnancy test will be done if the patient can’t verify this
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center
  • Physical exam, complete blood count (CBC) and multiphasic (including electrolytes, blood urea nitrogen [BUN], creatinine, total bilirubin, aspartate aminotransferase [AST], and alanine aminotransferase [ALT]) must be done within 28 days of PET imaging, but eligibility is not restricted by these results; the CBC and multiphasic may be drawn at the time of imaging
  • The medical monitor, Dr. Lois Ayash, at minimum, may discuss the research protocol with the investigators, interview human subjects, and consult with others outside of the study about the research, shall have authority to stop a research protocol in progress, remove individual human subjects from a research protocol, and take whatever steps are necessary to protect the safety and well-being of human subjects until the Institutional Review Board (IRB) can assess the monitor’s report; shall have the responsibility to promptly report their observations and findings to the IRB or other designate official and the Human Research Protection Office at the Department of Defense; the monitor may also observe recruitment and enrollment procedures and the consent process for individuals, groups or units overseeing study interventions and interactions, reviewing monitoring plans and reports; overseeing data matching, data collection and analysis

Locations & Contacts

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Anthony Frank Shields
Phone: 313-576-8735
Email: shieldsa@karmanos.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Evaluate the use of [F-18] FLT and PET to measure tumor proliferation and the activity of thymidine kinase.

II. Assess the changes that occur after therapy.

III. Compare the retention of [F-18] FLT in comparison to that of routine clinical measurements, such as computed tomography (CT), magnetic resonance imaging (MRI) or other imaging studies.

IV. Compare imaging proliferation data using [F-18] FLT to measurements of gene expression of proliferative and biochemical pathways made on tumor specimens obtained at biopsy.

OUTLINE:

Patients receive fluorothymidine F-18 intravenously (IV) and then undergo fluorothymidine F-18 positron emission tomography imaging over 150 minutes. Depending on the results of the first scan, patients may receive up to 3 additional scans which may be done during or after treatment.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Wayne State University / Karmanos Cancer Institute

Principal Investigator
Anthony Frank Shields

Trial IDs

Primary ID 2006-127
Secondary IDs NCI-2015-01345, NCI-2015-01231, 0905007082
Clinicaltrials.gov ID NCT00935090