Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma

This study is currently recruiting participants.
Verified June 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vicki Keedy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01882231
First received: May 29, 2013
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to investigate the ability of advanced quantitative imaging techniques to determine osteogenic tumor response. It is anticipated that the uptake and accumulation of [18F] Fluoro-L-thymidine ([18F]-FLT)will decrease in patients with osteosarcoma after one cycle of neoadjuvant chemotherapy (NAC). Furthermore, it is believed that the decrease in [18F]- (FLT) uptake, after one cycle of NAC, will significantly correlate with a decrease in tumor size and/or volume after two cycles of NAC.


Condition Intervention
Osteosarcoma
Paget's Disease
Other: MRI
Other: PET/CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Percent change in MRI metrics [ Time Frame: Pre-treatment and end of neoadjuvant cycle 1 ] [ Designated as safety issue: No ]
    Use 3T CEST-MRI, DW-MRI, and DCE-MRI to quantitatively measure protein content (APTasym), tumor cellularity (ADC), and tumor perfusion (Ktrans)and measure changes in these parameters from baseline to post 1 cycle of neoadjuvant chemotherapy.

  • Percent change in Standard Uptake Value from 18F-FLT-PET/CT [ Time Frame: Pre-treatment and at end of cycle 1 of neoadjvuant chemotherapy. ] [ Designated as safety issue: No ]
    employ [18F]-FLT-PET/CT to quantitatively measure tumor cell proliferation within osteogenic tumors before and after the first cycle of NAC with cisplatin/ doxorubicin/methotrexate.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death ] [ Designated as safety issue: No ]
    Duration from first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death for any reason

  • Percent of tumor necrosed at surgical resection [ Time Frame: At surgical resection, post-cycle 3 of neoadjuvant chemotherapy, or post-cycle 2 if tumor has progressed. ] [ Designated as safety issue: No ]
    Percent of necrosis in the excised tumor specimen determined by the reading pathologist.

  • Percent change in tumor size [ Time Frame: Pre-treatment and at the end of cycle 2 of neoadjuvant chemotherapy ] [ Designated as safety issue: No ]
    Standard of care imaging, either CT or MRI, will be performed prior to the initiation of neoadjuvant chemotherapy and at the end of cycle 2 using standard RECIST 1.1 guidelines.


Estimated Enrollment: 24
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dynamic CE and DW MRI, PET/CT-[18F]-fluorodeoxyglucose
Patients will have dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging modalities and/or integrated positron emission tomography/computerized tomography with [18F]-fluorodeoxyglucose studies performed before and after 1 cycle of chemotherapy.
Other: MRI
Imaging techniques using high-field MRI to make quantitative assessments
Other Name: dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging modalities
Other: PET/CT
Radiologic imaging techniques PET using [18F]-fluorodeoxyglucose as a tracer for PET to provide metabolic information together with CT scanning to provide anatomic information
Other Name: integrated positron emission tomographywith [18F]-fluorodeoxyglucose/computerized tomography

Detailed Description:

Patients with known osteosarcoma who are scheduled to receive neoadjuvant chemotherapy (NAC) will be enrolled on either the multi-parametric MRI component or the [18F]-FLT-PET/CT component, or both. In each component, each patient will undergo two separate scanning sessions at the following time points: 1) prior to the initiation of NAC; and 2) on Cycle 2 Day 1 (± 3 days) of NAC.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Aim 1):

  • Subjects must be 13 years of age or older.
  • Subjects (or their parent or legal guardian) must have signed Internal Review Board (IRB)-approved assent/informed consent documentation.
  • Subjects must have histologically proven osteogenic sarcoma, or malignant fibrous histiocytoma (MFH), of the pelvic or long bones.
  • Subjects must be planned for resection, this includes localized resectable disease or patients with metastatic disease with planned palliative resection, and scheduled to begin neoadjuvant chemotherapy

Exclusion Criteria (Aim 1):

  • Subjects who are under 13 years of age.
  • Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction.
  • Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
  • Subjects who have cerebral aneurysm clips.
  • Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
  • Subjects with inadequate renal function (creatinine ≥1.5 times upper limit of normal)or acute or chronic renal insufficiency (estimated glomerular filtration rate <30 mL/min).
  • Subjects who are pregnant or breast feeding, because the effects of high field MRI on fetuses are not yet known. Urine pregnancy test/or serum human chorionic gonadotropin (HCG) will also be performed on women of child bearing potential.
  • Subjects who have exhibited past allergic or other adverse reactions in response to intravenous injection of Magnevist® (gadopentetate dimeglumine) or other gadolinium-containing contrast agents.
  • Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore.

Subjects incapable of giving informed written consent, for the following reasons:

  • Inability to adhere to the experimental protocols for any reason
  • Inability to communicate with the research team
  • Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
  • Prisoners or other individuals deemed to be susceptible to coercion

Inclusion Criteria (Aim 2):

  • Subjects must be 18 years of age or older.
  • Subjects must have signed IRB-approved informed consent documentation.
  • Subjects must have histologically proven osteogenic sarcoma, or malignant fibrous histiocytoma (MFH), of the pelvic or long bones.
  • Subjects must be planned for resection, this includes localized resectable disease or patients with metastatic disease with planned palliative resection, and scheduled to begin neoadjuvant chemotherapy.

Exclusion Criteria (Aim 2)

  • Subjects who are under 18 years of age.
  • Subjects who are pregnant or breast feeding, because the effects of radiotracers and other contrast media used in PET/CT on fetuses are not yet known. Urine pregnancy test/or serum human chorionic gonadotropin (HCG) will also be performed on women of child bearing potential.

Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers or other PET/CT contrast media.

-Subjects incapable of giving informed written consent, for the following reasons:

  • Inability to adhere to the experimental protocols for any reason
  • Inability to communicate with the research team
  • Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
  • Prisoners or other individuals deemed to be susceptible to coercion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882231

Contacts
Contact: VICC Clinical Trials Information Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: VICC Clinical Trials Information Program         
Principal Investigator: Vicki Keedy, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Vicki Keedy, MD Vanderbilt-Ingram Cancer Study
  More Information

Additional Information:
No publications provided

Responsible Party: Vicki Keedy, MD, Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Assistant Medical Director, Clinical Trials Shared Resource; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01882231     History of Changes
Other Study ID Numbers: VICC SAR 1275, U01CA142565
Study First Received: May 29, 2013
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt-Ingram Cancer Center:
osteosarcoma
Paget's disease
bone cancer
childhood cancers

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014