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Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma

Information source: Children's Hospital of Philadelphia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neurofibromatosis Type 1; Precancerous Condition

Intervention: fludeoxyglucose F 18 (Radiation); gadopentetate dimeglumine (Radiation)

Phase: N/A

Status: Terminated

Sponsored by: Children's Hospital of Philadelphia

Official(s) and/or principal investigator(s):
Michael Fisher, MD, Study Chair, Affiliation: Children's Hospital of Philadelphia

Summary

RATIONALE: New imaging procedures such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) and magnetic resonance (MR) perfusion imaging may improve the ability to detect disease progression, help doctors predict a patient's response to treatment, and help plan the most effective treatment. PURPOSE: This diagnostic trial is studying how well FDG-PET and MR perfusion imaging work in finding disease progression and determining response to treatment in patients with neurofibromatosis 1 and plexiform neurofibroma.

Clinical Details

Official title: Novel Imaging Modalities For Plexiform Neurofibromas

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Tumor Progression as Measured by Tumor Area and Volume at 1 Year.

Detailed description: OBJECTIVES:

- Determine whether fludeoxyglucose F 18 positron emission tomography (FDG-PET) and MR

perfusion studies can predict plexiform neurofibroma growth rates in patients with neurofibromatosis 1.

- Determine whether FDG-PET and MR perfusion studies can predict the likelihood of

response in patients who are undergoing investigational treatment for plexiform neurofibromas.

- Identify neuroimaging characteristics that distinguish patients who have responded to

therapy from those who have not after completion of treatment. OUTLINE:

- Stratum 1: Patients undergo MR perfusion scan with gadopentetate dimeglumine and

fludeoxyglucose F 18 positron emission tomography (FDG-PET) at baseline and quantitative MRI evaluation at baseline and 1 year.

- Stratum 2: Patients undergo quantitative MRI, MR perfusion scan with gadopentetate

dimeglumine, and FDG-PET at baseline and 1 year. PROJECTED ACCRUAL: A total of 48 patients (32 for stratum 1 and 16 for stratum 2) will be accrued for this study.

Eligibility

Minimum age: N/A. Maximum age: 25 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Stratum 1:

- Diagnosis of neurofibromatosis 1 (NF1) and plexiform neurofibromas

- At high risk for progression, as defined by any of the following:

- Anatomic location such that progression carries a high risk of impairment

of function, pain, or disfigurement (e. g., neck/mediastinum, paraspinal nerve roots, orbit, and face)

- Tumors that the patient, family, or caregiver believes have increased in

size within the past year, but appear stable by standard clinical or radiographic measures

- No plexiform neurofibromas that are small, cause no pain or functional

impairment, or are not likely to cause pain or functional impairment over the succeeding 12 months

- Stratum 2:

- Diagnosis of NF1 and progressive plexiform neurofibromas

- Neurofibroma progression documented by increase in lesion size on MRI

- Currently being enrolled on a clinical therapeutic trial at Children's Hospital

of Philadelphia PATIENT CHARACTERISTICS: Age

- 25 and under

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy

- Not specified

Chemotherapy

- Stratum 1:

- No prior or concurrent chemotherapy

- No concurrent enrollment on a chemotherapy clinical trial

- Stratum 2:

- At least 4 weeks since prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- At least 6 weeks since prior radiotherapy (stratum 2)

Surgery

- Prior surgery for progressive plexiform neurofibroma allowed if incompletely resected

and measurable disease remains (stratum 2)

Locations and Contacts

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania 19104-4283, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Additional Information

Starting date: April 2002
Last updated: April 3, 2014

Page last updated: August 23, 2015

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