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Methionine PET/CT Studies In Patients With Cancer


N/A
N/A
N/A
Open (Enrolling)
Both
Brain Tumors and /or Solid Tumors Including:, Brain Stem Glioma, High Grade CNS Tumors, Ependymoma, Medulloblastoma, Craniopharyngioma, Low Grade CNS Tumors, Hodgkin Lymphoma, Non Hodgkin Lymphoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Neuroblastoma, Other

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Trial Information

Methionine PET/CT Studies In Patients With Cancer


The study focuses on the following objectives:

Primary objective:

- To estimate the success rate of Methionine (MET) for visualizing tumors at the time of
diagnosis. The study hypothesizes that at least 70% of newly diagnosed tumors within
each group will be studied and will be successfully visualized.

Secondary objective:

- To compare uptake of MET in tumors with tumor grade in patients with newly diagnosed or
relapsed, and/or persistent disease. Hypothesis: high grade tumors will concentrate
higher amounts of MET than lower grade tumors measured both qualitatively and
semi-quantitatively.

- To examine the bio-distribution of MET in organs that do not contain tumor, in
particular the lungs, heart, mediastinum, liver, spleen, pancreas, muscle, brain, and
bone marrow.

Exploratory objectives:

- To compare the findings on MET PET scans with those of standard imaging modalities,
principally MRI (magnetic resonance imaging) and FDG (fluorodeoxyglucose) PET CT
(computed tomography) at diagnosis, or at study enrollment for patients with relapsed
and or persistent disease, and for all patients over time.

- To compare the extent of abnormality on MRI with that of MET.

- To determine the presence or absence of elevated MET uptake beyond those of MRI defined
abnormality.

- To explore the relationship between MET uptake and prognosis.


Inclusion Criteria:



- All participants under the care of St. Jude physicians with known or suspected
neoplastic disease are eligible for participation.

- Participants will have had, or are scheduled to have clinical imaging evaluations
which may include FDG PET CT, or CT, or MRI within 4 weeks of entry.

- No limit on age or gender.

- Female participants of childbearing age must not be pregnant (confirmed by serum or
urine pregnancy test) or lactating due to theoretical potential harm to the
developing fetus or 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 6 MET PET scans within the previous 12 months.

- Inability or unwillingness of research participant, parent, or legal
guardian/representative to give written informed consent.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Success rate of methionine (MET) for visualizing tumors

Outcome Description:

To estimate the success rate of methionine (MET) for visualizing tumors at the time of diagnosis. We hypothesize that at least 70% of tumors within each group studied will be successfully visualized.

Outcome Time Frame:

Baseline

Safety Issue:

Yes

Principal Investigator

Barry L Shulkin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

METPET

NCT ID:

NCT00840047

Start Date:

May 2009

Completion Date:

May 2019

Related Keywords:

  • Brain Tumors and /or Solid Tumors Including:
  • Brain Stem Glioma
  • High Grade CNS Tumors
  • Ependymoma
  • Medulloblastoma
  • Craniopharyngioma
  • Low Grade CNS Tumors
  • Hodgkin Lymphoma
  • Non Hodgkin Lymphoma
  • Ewing Sarcoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Neuroblastoma
  • Other
  • Pediatric brain tumor
  • Pediatric solid tumor
  • Pediatric solid neoplasms
  • Brain Neoplasms
  • Craniopharyngioma
  • Adamantinoma
  • Ependymoma
  • Glioma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Medulloblastoma
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Central Nervous System Neoplasms
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794