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Whole Body MRI Screening for Li-Fraumeni Syndrome

N/A

Waitlist Available

Led By Allison O'Neill, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals with an inherited cancer predisposition syndrome such as Hereditary Retinoblastoma, Hereditary Paraganglioma/Pheochromocytoma Syndrome, Multiple Endocrine Neoplasia, opsoclonus-myoclonus, Familial Neuroblastoma, Rapid-onset Obesity with Hypothalamic dysfunction, Von Hippel-Lindau, or other rare cancer predisposition syndromes

Individuals with 'Li Fraumeni Syndrome' defined as carriers of a germline p53 mutation, members of families meeting classic LFS criteria by family history without an identifiable p53 mutation, or obligate carriers by pedigree

Must not have

Patients with a contraindication to sedation or general anesthesia

Females who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if MRI can be used to screen for cancer in people with LFS and other cancer predisposition syndromes.

Who is the study for?

This trial is for adults and children with Li-Fraumeni Syndrome or other inherited cancer predisposition syndromes. Participants must be in stable remission from any previous cancers, not pregnant, and able to give informed consent. It excludes those currently with active cancer (except certain types), pregnant/nursing women, and anyone with metal implants that affect MRI safety.

What is being tested?

The study is testing the use of Whole Body MRI as a screening method to detect early-stage cancers in individuals who have genetic conditions that make them more likely to develop cancer, such as Li-Fraumeni Syndrome.

What are the potential side effects?

Whole Body MRI does not involve radiation exposure like X-rays or CT scans; however, it may cause discomfort due to the need to remain still for long periods. There's also a small risk of allergic reaction if contrast dye is used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a genetic condition that increases my cancer risk.

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I have Li Fraumeni Syndrome or a family history suggesting it.

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I am under 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have sedation or general anesthesia due to health reasons.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radionuclide Imaging

Secondary study objectives

Detection of prevalent and incident cancers on WB-MRI in pediatric and adult patients with Li Fraumeni and other inherited cancer predisposition syndromes.

Malignant Neoplasms

Return of pediatric and adult patients with other cancer predisposition syndromes year-after-year for 4 annual scans.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Whole Body MRIExperimental Treatment1 Intervention

* Magnetic resonance imaging will be performed on participants * Participants who are two young to tolerate the scans awake, can receive sedation/anesthesia

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Whole Body MRI

2007

N/A

~40

0 / 5Eligibility criteria met