search
Back to results

Expanded Access [11C] Methionine PET Imaging

Primary Purpose

Central Nervous System Tumor, Head and Neck Neoplasms

Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
L-(11C) methionine
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Central Nervous System Tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation.
  • No limit on age.
  • Patients of all genders and all ethnic groups under the care of a SJCRH physician.
  • Female participants of child-bearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
  • Informed consent signed by participant, parent, or guardian according to the guidelines of the Institutional Review Board.

Exclusion Criteria:

  • More than six L-[11C]methionine PET scans within the previous 12 months.
  • Inability or willingness of patient, parent, or guardian to consent.

Sites / Locations

  • St. Jude Children's Research Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 19, 2022
Last Updated
August 22, 2023
Sponsor
St. Jude Children's Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05511714
Brief Title
Expanded Access [11C] Methionine PET Imaging
Official Title
Expanded Access [11C] Methionine PET Imaging
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

5. Study Description

Brief Summary
The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment. Primary Objective To provide expanded access to L-[11C]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.
Detailed Description
Participants receive an intravenous injection of a small (tracer) dose of L-[11C]methionine. Approximately 10 minutes later, patients undergo PET scanning to evaluate localization of the tracer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Tumor, Head and Neck Neoplasms

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-(11C) methionine
Other Intervention Name(s)
methionine C 11
Intervention Description
Injected intravenously with 20 mCi/1.7 sq m body surface area of L-[methyl-11C]methionine (maximum prescribed dose: 20 mCi).

10. Eligibility

Sex
All
Eligibility Criteria
Inclusion Criteria: All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation. No limit on age. Patients of all genders and all ethnic groups under the care of a SJCRH physician. Female participants of child-bearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation. Informed consent signed by participant, parent, or guardian according to the guidelines of the Institutional Review Board. Exclusion Criteria: More than six L-[11C]methionine PET scans within the previous 12 months. Inability or willingness of patient, parent, or guardian to consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barry L. Shulkin, MD, MBA
Phone
866-278-5833
Email
referralinfo@stjude.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry L. Shulkin, MD, MBA
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry L. Shulkin, MD, MBA
Phone
866-278-5833
Email
referralinfo@stjude.org
First Name & Middle Initial & Last Name & Degree
Barry L. Shulkin, MD, MBA

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude

Learn more about this trial

Expanded Access [11C] Methionine PET Imaging

We'll reach out to this number within 24 hrs