Brain NeoplasmNCT00001574
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
An observational study of Brain Neoplasm and Brain Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Brain Neoplasm, Brain Cancer, Brain Tumor, Primary
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 1997to 6 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read the detailed description
Background:
- Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
- 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.
Objective:
- To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
- To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.
Eligibility:
- Age less than or equal to 21 years.
- Patients entered on this trial will also be entered on one of the Branch s primary brain tumor treatment trials.
- Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
- Measurable or evaluable tumor at the time of study entry.
Design:
- This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
- Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
- Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.
- Conditions
- Brain Neoplasm, Brain Cancer, Brain Tumor, Primary
- Keywords
- Metabolites, Proton Nuclear Magnetic Resonance Spectroscopic Imaging, Scans
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at time of disease evaluation
Secondary outcomes (2)
Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema
measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)
Measured: at time of disease evaluation
Determine if early metabolic changes are predictive of response
Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery
Measured: at time of disease evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start14 Mar 1997
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Katherine E Warren, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001574
- Sponsor's protocol ID
- 970093
- Other IDs
- 97-C-0093
- Status last verified
- 6 May 2019
- First submitted
- 3 Nov 1999
- Last updated
- 8 May 2019
- Results posted
- No
Publications
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.
PubMed 8770242Sutton 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.
PubMed 1513425Duyn 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.
PubMed 8511313
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT00001574
- Acronym / sponsor ID
- 970093
- Conditions
- Brain Neoplasm, Brain Cancer, Brain Tumor, Primary
- Keywords
- Metabolites, Proton Nuclear Magnetic Resonance Spectroscopic Imaging, Scans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Mar 1997
- Study completion
- 6 May 2019
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
- 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.
Objective:
- To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
- To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.
Eligibility:
- Age less than or equal to 21 years.
- Patients entered on this trial will also be entered on one of the Branch s primary brain tumor treatment trials.
- Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
- Measurable or evaluable tumor at the time of study entry.
Design:
- This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
- Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
- Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors.
Time frame: at time of disease evaluation
in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect
2 secondary outcomes
Distinguish spectroscopic patterns associated with tumor progression, necrosis and edema
Time frame: at time of disease evaluation
Determine if early metabolic changes are predictive of response
Time frame: at time of disease evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Background: PubMed 8770242Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. No abstract available.
- Background: PubMed 1513425Sutton 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.
- Background: PubMed 8511313Duyn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine E Warren, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasm and Brain Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define specific patterns of metabolises using long-echo time multislice proton nuclear magnetic resonance spectroscopic imaging in pediatric patients with brain tumors. (time frame: at time of disease evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001574, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.