A surveillance study investigating whole body magnetic resonance imaging and other diagnostic procedures in people at high risk of cancer

A surveillance study utilizing whole body magnetic resonance imaging and other surveillance procedures in people with germ line cancer gene mutations to investigate the prevalence and incidence of investigable lesions.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000987763

Acronym

SMOC +

Enrollment

296

Registered

2013-09-04

Start date

2013-07-09

Completion date

2031-09-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is investigating whole body magnetic resonance imaging (MRI) and other diagnostic procedures in people at high risk of cancer. Who is it for? You may be eligible to join this study if you are aged between 18-70 years, and are a known NF1 patient, OR a known cancer risk gene mutation carrier, OR have a family member at 50% risk of carrying a mutation. You will not be eligible if you have an active cancer diagnosis. Study details - All participants in this study will have an initial clinical review followed by annual diagnostic procedures for a period of 3 years. This may include annual whole body MRI scans, breast MRI (females only), fecal occult blood test and full blood count. Additional investigations including colonoscopy and upper gastrointestinal endoscopy may also be conducted at varying time points, as indicated by family history and clinical appropriateness. Participants will also be asked to complete psychosocial questionnaires and invited to participate in in-depth interviews. This study will provide estimates of the prevalence and incidence of investigable lesions, and the acceptability, safety, psychosocial impact, and cost-effectiveness of the screening protocol. This information will be used to design a large scale screening project.

Interventions

Annual whole body magnetic resonance imaging, general physical exam, full blood count, and breast MRI, US and mammography(females). Other diagnostic procedures include colonoscopy and gastroscopy as indicated by family history. The study period is 3 years. Adherence to the study protocol will be monitored by accessing medical records.

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Known cancer risk gene pathogenic mutation carrier or family member at 50% risk of carrying a mutation ECOG performance status 0 or 1 No active cancer diagnosis. This is defined as the primary tumour having been treated with no clinical or symptomatic evidence of metastatic disease Expected lifespan greater than 3 years

Exclusion criteria

Inability to provide informed consent Serious co-morbid illness Active cancer diagnosis Inability to undergo study procedures Inability to understand an English language consent form Pregnancy

Outcome results