Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorM.D. Anderson Cancer Center

About this trial

This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent will be obtained from each participants including healthy volunteers.

Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.

All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial

Patient is >18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.

Disqualifiers

Healthy volunteers will be screened using same process but will otherwise not be subject to other selection criteria.

The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.

Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: • electronically, magnetically, and mechanically activated implants • ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostatic clips in the central nervous system (CNS) or body • cochlear implants • other pacemakers, e.g., for the carotid sinus • insulin pumps and nerve stimulators • non-MR safe lead wires • prosthetic heart valves (if dehiscence is suspected) • non-ferromagnetic stapedial implants • pregnancy • claustrophobia that does not readily respond to oral medication

Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the patient from participation. Remote history (> 6month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperpolarized Carbon C 13 Pyruvate

    Drug

    Given IV

  • Magnetic Resonance Spectroscopic Imaging

    Procedure/Surgery

    Undergo MRSI

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: Diagnostic (carbon C 13 pyruvate, MRSI)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data

The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.

Time frame
Up to 1 year

Secondary outcomes

1

Ki-67 quantitation

Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used.

Time frame
Up to 1 year
2

Tumor kpl values

Will compare with normal brain kpl values. Linear mixed models will be used.

Time frame
Up to 1 year
3

Normal brain kpl values

Will compare with tumor kpl values. Linear mixed models will be used.

Time frame
Up to 1 year
4

Pathology results

Correlation with kpl values will be determined through generalized linear mixed models.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator