MCT for the Harvard/UCSF ROBIN Center

Part of paid clinical trials in San Francisco, California.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06000787
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • External beam radiotherapy — RADIATION
    Subjects with diffuse midline glioma on PNOC023 (NCT04732065) Arm A or B receive standard-of-care external beam radiotherapy to the brain tumor.
  • 131I-Metaiodobenzylguanidine (MIBG) — RADIATION
    Subjects with high-risk neuroblastoma on COG ANBL1531 (NCT03126916) Arm B receive the radiopharmaceutical 131I-Metaiodobenzylguanidine (MIBG) 15 mCi/kg via either a central or a peripheral IV catheter over 1.5 to 2 hours at a maximum rate of 500 mCi/hour.

Study Details

The goal of the Molecular Characterization Trial (MCT) is to obtain biological specimens and data resources from patients enrolled on prospective trials, to ensure that the Harvard/UCSF ROBIN Center accomplishes its key objective of advancing our understanding of the biological mechanisms that underlie how radiation treats tumors but also can cause unwanted side effects. The MCT focuses on collection of research biospecimens before, during, and after radiation. Also critical to the MCT is the deep annotation of these research biospecimens with elements that complement each other to provide a holistic, detailed view of each patient. Annotated elements include those used in the past such as clinical and biological features but extend to factors we have so far neglected but must incorporate in the future such as dosimetry (precise anatomical measurement of radiation dose), artificial intelligence, computational biology, and natural language processing.

Key Dates

Start date
Sep 19, 2023
Status verified
Jan 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
47 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Diffuse Midline Glioma
    Subjects with diffuse midline glioma on PNOC023 (NCT04732065) Arm A or B
  • Other: Neuroblastoma
    Subjects with high-risk neuroblastoma on COG ANBL1531 (NCT03126916) Arm B

Primary Outcome Measure

Event-free survival by tumor heterogeneity [ Time Frame: up to 3 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Sabine Mueller, MD, PhD
Brigham and Women's HospitalBostonMassachusetts02115
David Kozono, MD, PhD
David Kozono, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
University of California, San Francisco· San Francisco, CABrigham and Women's Hospital· Boston, MA

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