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Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors

This study is currently recruiting participants.
Verified July 2017 by Sabine Mueller, MD, PhD, University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02947373
First Posted: October 27, 2016
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sabine Mueller, MD, PhD, University of California, San Francisco
  Purpose

This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC).

The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors.


Condition Intervention Phase
Pediatric Brain Tumors Drug: Hyperpolarized Pyruvate Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PNOC 011: Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors

Resource links provided by NLM:


Further study details as provided by Sabine Mueller, MD, PhD, University of California, San Francisco:

Primary Outcome Measures:
  • Number of Participants With Adverse Events as Assessed by CTCAE v4.0. Analyses will be performed for all patients having received at least one dose of study drug. [ Time Frame: 9 months ]
    DLT will be assessed by monitoring for adverse events, scheduled laboratory assessments, vital sign measurements, ECGs, and physical examinations. The severity of the toxicities will be graded according to the NCI CTCAE v4.0. Adverse events and clinically significant laboratory abnormalities will be summarized by maximum intensity and relationship to study drug. Safety will be assessed during the infusion and at least for one hour after completion of the infusion as well as by phone 24 hours after the infusion. Descriptive statistics will be utilized to display the data on toxicity seen.


Secondary Outcome Measures:
  • Secondary analyses will include assessment of imaging quality, which will be descriptive in nature. [ Time Frame: 12 months ]

    13C data will be acquired using the following sequence parameters;

    • a volumetric acquisition from a 4-5cm slice with 2D phase encoding and 1-D EPSI encoding, field of view 20x24x10cm (1cc voxel size),
    • 1H scout; A further set of scout images will be obtained to re-establish appropriate landmarks.
    • High resolution anatomic imaging: These require a 3D localizing scan to define the graphical prescription;
    • Diffusion Images: This will be followed by diffusion tensor spin echo single shot echo planar images, 6 gradient directions, 22cm FOV, 128x128 matrix,
    • Lactate edited 3D MRSI: water suppressed 1H MRS with PRESS volume selection, out-of-voxel suppression with very spatially selective rf pulses, echo planar encoding in the SI direction and 2D in-plane phase encoding


Estimated Enrollment: 9
Actual Study Start Date: January 25, 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Imaging Arm
Patients will receive a one-time injection of Hyperpolarized Pyruvate prior to a single MR imaging examination that includes the acquisition of HP carbon-13 metabolic data.
Drug: Hyperpolarized Pyruvate
Hyperpolarized Pyruvate

Detailed Description:

This is an open label trial to assess the safety and tolerability of the adult tolerated dose of Hyperpolarized Pyruvate (HP) for metabolic imaging in children with brain tumors who do not require sedation for their MR imaging. Nine patients will receive a single MR imaging examination that includes the acquisition of hyperpolarized 13C metabolic data in combination with anatomic, diffusion, perfusion and lactate edited 1H spectroscopic imaging data. The data will be processed using custom designed software to estimate changes in levels of lactate/pyruvate and to relate them to abnormalities observed in the data from other MR modalities.

The results of this study will provide the safety data required to move this type of metabolic imaging into therapeutic trials to assess the utility of HP 13C lactate/pyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ≥ 3 years and ≤ 18 years of age with a diagnosis of a brain tumor and who do not require sedation for MR imaging
  • Karnofsky ≥ 70 for patients ≥ 16 years of age, and Lansky ≥ 70 for patients < 16 years of age (See Appendix 1 Performance Status Criteria)
  • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent
  • Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of starting treatment. Effective contraception (men and women) must be used in subjects of child-bearing potential
  • Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent

Exclusion Criteria:

  • Patients who are not able to comply with study and/or follow-up procedures
  • Patients receiving active therapy on an investigational trial at the time of enrollment should consult with the study chair regarding potential interactions with other study agents. Patients who are enrolled in a clinical trial but are off- therapy and in follow up are eligible.
  • Patients with history or evidence of cardiac dysfunction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947373


Contacts
Contact: Sabine Mueller, MD, PhD, MAS (415) 476-3831 sabine.mueller@ucsf.edu
Contact: PNOC Regulatory (415) 502-1600 PNOC_regulatory@ucsf.edu

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94158
Contact: Sabine Mueller, MD    415-476-3831    sabine.mueller@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Sabine Mueller, MD, PhD, MAS University of California, San Francisco
  More Information

Responsible Party: Sabine Mueller, MD, PhD, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02947373     History of Changes
Other Study ID Numbers: PNOC 011
16088 ( Other Identifier: University Of California, San Francisco HDCC )
First Submitted: October 24, 2016
First Posted: October 27, 2016
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sabine Mueller, MD, PhD, University of California, San Francisco:
brain tumor
children

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases