- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00934401
Positron Emission Mammography With Fluorothymidine (FLT) to Evaluate Treatment Response to Chemotherapy in Breast Cancer
7. juli 2016 opdateret af: Yusuf Menda, University of Iowa
Positron Emission Mammography With 3'-Deoxy-3'-[18F] Fluorothymidine (FLT PEM) for Evaluation of Response to Neoadjuvant Chemotherapy in Breast Cancer
Positron Emission Tomography Imaging with 3-Deoxy-3'-[18F]Fluorothymidine (FLT) can selectively identify proliferating and non-proliferating tissues, including tumors.
FLT uptake in the tumor is an indirect marker of DNA synthesis activity, which is a target of chemotherapy.
Our hypothesis is that early change in FLT uptake in tumor with chemotherapy will predict pathological response to neoadjuvant therapy in breast cancer.
Tumor uptake of FLT will be imaged and measured with positron emission mammography (PEM), a PET scanner optimized for breast imaging with a significantly improved resolution compared to conventional whole-body PET imaging systems.
Studieoversigt
Status
Trukket tilbage
Betingelser
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- The University of Iowa Hospitals & Clinics PET Center
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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
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Women diagnosed with breast cancer whose recommended treatment is neoadjuvant chemotherapy followed by surgical resection.
Beskrivelse
Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent document.
- Subject must have histologically confirmed breast cancer.
- Subject must be scheduled to receive neoadjuvant chemotherapy followed by surgery for their standard cancer care. Treatment decisions will be made by the treating surgeon and the medical oncologist.
- Females at least 18 years of age.
- Karnofsky at least 60% at time of screening.
- Life expectancy of greater than 6 months.
Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:
- leukocytes at least 3,000/microL
- absolute neutrophil count at least 1,500/microL
- platelets at least 100,000/microL
- total bilirubin Equal or less than 1.0 mg/dl
- AST(SGOT) no greater than 2.5 X institutional upper limit of normal
- ALT (SGPT) no greater than 2.5 X institutional upper limit of normal
- Creatinine Equal or less than 1.4 mg/dl
- BUN Equal or less than 20 mg /dl
- The effects of FLT on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine hCG will be administered in the Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will not be accepted as subjects in this study.
Exclusion Criteria:
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Subject with a Karnofsky score of below 60.
- Pregnant women are excluded from this study. FLT PET has potential for teratogenic effects. Because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with FLT, breastfeeding should be discontinued if the mother is imaged with FLT and may not resume for 48 hours after the FLT imaging.
- Subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Uptake of FLT (SUV) within the tumor
Tidsramme: 20 mintues and 60 minutes post injection
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20 mintues and 60 minutes post injection
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pathologic tumor response
Tidsramme: 3 months
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3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yusuf Menda, M.D., The University of Iowa Hospitals & Clinics
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. juli 2009
Primær færdiggørelse (Faktiske)
1. maj 2010
Studieafslutning (Faktiske)
1. maj 2010
Datoer for studieregistrering
Først indsendt
6. juli 2009
Først indsendt, der opfyldte QC-kriterier
7. juli 2009
Først opslået (Skøn)
8. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 200903755
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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