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Can Full-Body scans spot cancer early in High-Risk families?

NCT ID NCT02950987

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2012

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

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Other studies related to the condition(s) this trial covers.