Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT02947373|
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : June 28, 2018
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 or disease||Intervention/treatment||Phase|
|Pediatric Brain Tumors||Drug: Hyperpolarized Pyruvate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PNOC 011: Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors|
|Actual Study Start Date :||January 25, 2017|
|Estimated Primary Completion Date :||December 15, 2018|
|Estimated Study Completion Date :||February 2019|
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
- 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 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
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
|Contact: Sabine Mueller, MD, PhD, MAS||(415) firstname.lastname@example.org|
|Contact: PNOC Regulatory||(415) 502-1600||PNOC_regulatory@ucsf.edu|
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Sabine Mueller, MD 415-476-3831 email@example.com|
|Study Chair:||Sabine Mueller, MD, PhD, MAS||University of California, San Francisco|