A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

NCT00001574 | Completed

• 2 other identifiers: 97009397-C-0093
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Brain tumors represent the most common solid tumor of childhood. Treatment generally entails surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements routine MRI by giving chemical information in conjunction with spatial information obtained by MRI. This study will be conducted to determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Conditions

Brain Neoplasm; Brain Cancer; Brain Tumor, Primary

Keywords

Metabolites; Proton Nuclear Magnetic Resonance Spectroscopic Imaging; Scans

Outcome Measures

Primary Outcomes (1)

• To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors.

  in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect

  at time of disease evaluation

Secondary Outcomes (2)

• Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema

  at time of disease evaluation

• Determine if early metabolic changes are predictive of response

  at time of disease evaluation

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age less than or equal to 21 years.
• Patients entered on this trial will also be entered on one of the Pediatric Oncology Branch's primary treatment trials (e.g., phenylacetate, phenylbutyrate, SU-101) or on the Natural History or Standard Therapy protocols. The patient's management will be determined by the primary treatment protocol.
• Histology confirmed primary or metastatic brain tumor. Patients with a brainstem glioma are not required to have previously had a histologic diagnosis.
• Measurable or evaluable tumor at the time of study entry.
• Durable Power of Attorney (DPA): A DPA is required of all patients 18 - 21 years of age.
• All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. When appropriate the minor patient will give verbal assent.

You may not qualify if:

• Pregnant women.
• Any patient who is unable (either because of physical or psychological factors) to undergo imaging studies and who is not an anesthesia candidate.
• Any patient with a metallic implant, including cardiac pacemakers, neural pacemakers, shrapnel, cochlear implants or ferrous surgical clips.
• Any patient with a history of a severe reaction to Gadolinium or other contrast agents.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. No abstract available.

  PMID: 8770242 BACKGROUND

• Sutton LN, Wang Z, Gusnard D, Lange B, Perilongo G, Bogdan AR, Detre JA, Rorke L, Zimmerman RA. Proton magnetic resonance spectroscopy of pediatric brain tumors. Neurosurgery. 1992 Aug;31(2):195-202. doi: 10.1227/00006123-199208000-00004.

  PMID: 1513425 BACKGROUND

• Duyn JH, Gillen J, Sobering G, van Zijl PC, Moonen CT. Multisection proton MR spectroscopic imaging of the brain. Radiology. 1993 Jul;188(1):277-82. doi: 10.1148/radiology.188.1.8511313.

  PMID: 8511313 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katherine E Warren, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: March 14, 1997
• Study Completion: May 6, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05-06

Locations

US (1)