Can Full-Body scans spot cancer early in High-Risk families?
NCT ID NCT02950987
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether whole body MRI scans can help find cancers early in children and adults with Li-Fraumeni syndrome, a genetic condition that greatly raises cancer risk. About 150 participants will receive annual whole body MRI scans for four years to see if they keep coming back for screening and how many cancers are detected. The goal is to see if this imaging approach is a practical and effective screening tool for this high-risk group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Whole Body MRI (imaging device)
- What this could lead to
- If successful, this could establish whole body MRI as a standard screening method to catch cancers early in people with Li-Fraumeni syndrome, potentially improving survival.
- What could go wrong
- This is an observational screening study, not a treatment trial. It may not prove that earlier detection actually improves outcomes, and false positives could cause unnecessary anxiety or procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2012
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults * Individuals greater than or equal to 18 years of age. * Individuals with "Li Fraumeni Syndrome" defined as one of the following: * Carriers of a germline p53 mutation * Members of families meeting classic LFS criteria by family history without an identifiable p53 mutation * Obligate carrier by pedigree (these individuals can be offered testing but are still eligible if they defer). The following examples describe "obligate carriers by pedigree." * A child of a parent with known p53 mutation that is diagnosed with cancer * An individual with a sibling and a child who are p53 positive -OR- * Individuals with an inherited cancer predisposition syndrome as defined by one of the following: * Hereditary Retinoblastoma with a germline Rb mutation * Diagnosis of Hereditary Paraganglioma/Pheochromocytoma Syndrome with a germline SDH mutation * Diagnosis of Multiple Endocrine Neoplasia, Type 1 or 2, with a germline MEN mutation * New diagnosis of opsoclonus-myoclonus with a negative cancer work-up upon presentation of symptoms * Familial Neuroblastoma with a germline ALK mutation * Rapid-onset Obesity with Hypothalamic dysfunction, Hypoventilation and Autonomic Dysregulation (ROHHAD syndrome) or Congenital central hypoventilation syndrome (CCHS) with or without a germline PHOX 2B mutation * Von Hippel-Lindau with a VHL mutation * Women with an abnormal cell-free DNA test (i.e. a non-invasive prenatal test (NIPT) to detect chromosomal abnormalities) and no cancer diagnosis * Other rare cancer predisposition syndromes at the discretion of the treating physician and study physicians * NOTE: Individuals with any of the above-listed cancer predisposition syndromes (apart from Li Fraumeni syndrome) are likewise eligible in the absence of a known mutation if they are an obligate carrier by pedigree. * Individuals can have a prior history of cancer; these individuals must be in stable remission and at least 6 months out from the completion of surgery/radiation\\ therapy/chemotherapy. * Individual cases can be reviewed with the institutional principal investigator. * Individuals not pregnant at enrollment. Female subjects of childbearing potential will undergo a pregnancy test prior to imaging. * Individuals able to give informed consent or a signature from a designated health care proxy or legal guardian. Children * Individuals who are less than 18 years of age * Individuals with "Li Fraumeni Syndrome" defined as one of the following: * Carriers of a germline p53 mutation OR * Members of families meeting classic LFS criteria by family history without an identifiable p53 mutation OR * Obligate carrier by pedigree (these individuals can be offered testing but are still eligible if they defer). The following examples describe "obligate carriers by pedigree." * A child of a parent with known p53 mutation that is diagnosed with cancer * An individual with a sibling and a child who are p53 positive -OR- * Individuals with an inherited cancer predisposition syndrome as defined by one of the following: * Hereditary Retinoblastoma with a germline Rb mutation * Diagnosis of Hereditary Paraganglioma/Pheochromocytoma Syndrome with a germline SDH mutation * Diagnosis of Multiple Endocrine Neoplasia, Type 1 or 2, with a germline MEN mutation * New diagnosis of opsoclonus-myoclonus with a negative cancer work-up upon presentation of symptoms * Familial Neuroblastoma with a germline ALK mutation * Rapid-onset Obesity with Hypothalamic dysfunction, Hypoventilation and Autonomic Dysregulation (ROHHAD syndrome) or Congenital central hypoventilation syndrome (CCHS) with or without a germline PHOX 2B mutation * Von Hippel-Lindau with a VHL mutation * Other rare cancer predisposition syndrome at the discretion of the treating physician and study physicians * NOTE: Individuals with any of the above-listed cancer predisposition syndromes (apart from Li Fraumeni syndrome) are likewise eligible in the absence of a known mutation if they are an obligate carrier by pedigree. * Individuals can have a prior history of cancer; these individuals must be in stable remission and at least 6 months out from the completion of surgery/radiation therapy/chemotherapy. Individual cases can be reviewed with the institutional principal investigator. * Individuals not pregnant at enrollment. Female subjects of childbearing potential will undergo a pregnancy test prior to imaging. * Signed document of informed consent completed by the parent or legal guardian * Signed document of assent obtained if child ≥10 years of age Exclusion Criteria: Adults and Children * Active cancer or metastatic disease, except in the case of Stage 0 Chronic Lymphocytic Leukemia or nonmelanoma skin cancer. * Patients with a contraindication to sedation or general anesthesia * Patients with a metal heart valve, surgical clips, a pacemaker or any other indwelling metal device that might interfere with MRI * Females who are pregnant or nursing
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
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