- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05268913
Towards Early Detection of Breast Cancer in High Risk Population (READ RISK)
Robust EArly Detection of bReast Cancer in hIgh riSK Premenopausal Population Using Novel Lipid Based Imaging Methods
Breast cancer is a major and growing health challenge, and the leading cause of cancer in women. As population obesity rates increase, the number of new breast cancer diagnosis continues to rise. Despite treatment advances, breast cancer remains an important cause of premature mortality, taking women in the prime of life. Although underlying susceptibility caused by mutation in the genes including BRCA1/2 is increasingly identified, current pre-symptomatic screening for the general population and those at high genetic risk remains sub-optimal, with high false negative and positive rates.
Alteration of breast lipid composition has been observed by us and others in patients with breast cancer and is thought to precede onset. We have developed and tested a novel method to allow a standard 3T MRI scanner to perform quantitative 3D mapping of specific lipid molecules in the breast.
We will investigate if this method can detect very early breast cancers, and compare the amount and spread of lipid composition in breast tissue of premenopausal women with very high genetic risk of breast cancer, women with breast cancer and women with obesity.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
Aberdeenshire
-
Aberdeen, Aberdeenshire, Storbritannien, AB25 2ZD
- Aberdeen Biomedical Imaging Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
-
Women with BRCA1/2 genes:
- female 18-55 years old, premenopausal
- BRCA 1/2 gene carriers
- not having any metabolic disorders (e.g., diabetes)
- not on any long term medications that may affect lipid metabolism (e.g., statins)
- BMI < 30
Women with breast cancer (no obesity):
- females 18-55 years old, premenopausal
- confirmed diagnosis of invasive ductal carcinoma of the breast
- not having any metabolic disorders (e.g., diabetes)
- not on any long term medications that may affect lipid metabolism (e.g., statins)
- BMI < 30
Women with breast cancer (obesity):
- BMI > 30
- otherwise as women with breast cancer
Women with obesity:
- females 18-55 years old, premenopausal
- not having any metabolic disorders (e.g., diabetes)
- not on any long term medications that may affect lipid metabolism (e.g., statins)
- BMI > 30
Exclusion Criteria:
- females under 18 or over 55 years old, postmenopausal
- males
- have metabolic disorders (e.g., diabetes)
- on long term medications that may affect lipid metabolism (e.g., statins)
- contraindicated for MR investigation (poor renal function and metal implants)
- (for patients) concurrent cancer in other sites
- (for patients) started hormone treatment, chemotherapy or breast surgery
- non-English speakers
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Women with BRCA1/2 genes
|
Participants will undertake a magnetic resonance imaging scan.
Participants will undertake a fasting blood test.
|
Women with breast cancer
|
Participants will undertake a magnetic resonance imaging scan.
Participants will undertake a fasting blood test.
|
Women with obesity
|
Participants will undertake a magnetic resonance imaging scan.
Participants will undertake a fasting blood test.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Amount of lipid composition in the breast
Tidsram: One hour
|
The percentage of monounsaturated fatty acids, polyunsaturated fatty acids and saturated fatty acids relative to total lipid will be measured using magnetic resonance imaging (MRI) scanner software and MATLAB computer programme. Unit of Measurement: %. |
One hour
|
Spatial distribution (skewness) of lipid composition in the breast
Tidsram: One hour
|
Skewness measures the asymmetry in distribution. The skewness of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme. Unit of Measurement: unitless. |
One hour
|
Spatial distribution (entropy) of lipid composition in the breast
Tidsram: One hour
|
Entropy measures the randomness in distribution. The entropy of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme. Unit of Measurement: unitless. |
One hour
|
Spatial distribution (kurtosis) of lipid composition in the breast
Tidsram: One hour
|
Kurtosis measures the peakedness in distribution. The kurtosis of lipid composition in the breast will be measured using MRI scanner software and MATLAB computer programme. Unit of Measurement: unitless. |
One hour
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2-102-21
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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