- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00943527
Hormonal Effects on Tc-99m Sestamibi Uptake in the Breast
23. januar 2012 opdateret af: Deborah Rhodes, Mayo Clinic
Molecular Breast Imaging: Effect of Menstrual Cycle, Hormone Therapy, and Tamoxifen on Tc-99m Sestamibi Uptake in the Breast.
This study is to examine the effects of menstrual cycle, hormone therapy, and the use of tamoxifen on Tc-99m sestamibi uptake.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
110
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
35 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Community Sample
Beskrivelse
Arm 1
Inclusion Criteria:
- age 35-45
- have regular menstrual cycles as defined by having menstrual cycle length of 25-31 days, with menstrual flow of 2-7 days, and no intermenstrual spotting or bleeding.
- have had a negative screening mammogram within one year prior to the MBI studies that is available for comparison.
Exclusion Criteria:
- currently using any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones) or any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors
- have a personal history of any cancer, except non-melanomatous skin cancer
- unable to understand and sign the consent form
- pregnant or lactating
- physically unable to sit upright and still for 30 minutes
Arm 2
Inclusion Criteria:
- scheduled to begin one of the following regimens of HT:
- Any dosage of any formulation of systemic estrogen therapy in the setting of a prior hysterectomy
- Any dosage of continuous estrogen plus monthly, cyclic progesterone therapy where the progesterone therapy is the oral, micronized formulation
- had a negative screening mammogram within one year prior to the MBI studies that is available for comparison.
Exclusion Criteria:
- have a personal history of any cancer, except non-melanomatous skin cancer
- unable to understand and sign the consent form
- pregnant or lactating
- physically unable to sit upright and still for 30 minutes
Arm 3
Inclusion Criteria:
- scheduled to begin treatment with tamoxifen Or are currently being treated with tamoxifen (for > 1 month) and have had an MBI scan performed prior to its initiation
- have had or will have the following test performed at Mayo Clinic: #87966, Cytochrome P450 2D6 genotyping for Tamoxifen Hormonal Therapy
- have had a screening or diagnostic mammogram within one year of the MBI studies that is available for comparison.
Exclusion Criteria:
- are using or have used any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones), any estrogen receptor modulating drugs other than tamoxifen, or any aromatase inhibitors from the time of 1 month prior to the first MBI until completion of the second MBI.
- have been treated or will be undergoing treatment with systemic chemotherapy or external radiation beam therapy to the breast from the time of 6 months prior to the first MBI until the completion of the second MBI.
- unable to understand and sign the consent form
- pregnant or lactating
- physically unable to sit upright and still for 30 minutes
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
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1
Premenopausal Women who are not taking hormones or birth control.
Ages 35-45 who have had a negative mammograph performed at the Mayo Clinic in Rochester within the last year.
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2
Women Initiating Hormone Therapy and have had a negative mammogram preformed at the Mayo Clinic Rochester within the last year.
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3
Women Initiating Tamoxifen who have had a negative mammogram preformed at the Mayo Clinic Rochester.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2008
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først indsendt
20. juli 2009
Først indsendt, der opfyldte QC-kriterier
21. juli 2009
Først opslået (Skøn)
22. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. januar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. januar 2012
Sidst verificeret
1. januar 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07-004850
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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