- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00572598
Pilot Study of 18F Fluoropaclitaxel (FPAC)
Pilot Study of 18F Fluoropaclitaxel (FPAC) in Breast Cancer Patients and Normal Volunteers: Dosimetry and Imaging Feasibility
Multidrug resistance (MDR) is a cause of treatment failure in many cancer patients. MDR refers to a phenotype whereby a tumor is resistant to a large number of natural chemotherapeutic drugs. Having prior knowledge of the presence of such resistance would decrease morbidity from unsuccessful therapy and allow for the selection of individuals who may benefit from co-administration of MDR inhibiting drugs. The Tc-99m labeled single photon emitting radiotracers sestamibi and tetrofosmin have shown some predictive value. However, positron-emitting (PET) radiotracers, which allow for dynamic, quantitative imaging, hold the promise of more accurate and specific identification of MDR tumors.
Objective:
To obtain human safety data, to demonstrate imaging feasibility with FPAC, to obtain human biodistribution and to obtain preliminary evidence of breast tumor uptake concordance with response to therapy.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
18F flouropaclitaxel (FPAC) distribution in malignant tumors is expected to be similar to that of paclitaxel. It is proposed that by monitoring the influx and efflux of FPAC in vivo using PET imaging, we will be able to determine if a tumor retains the drug (is drug sensitive) or pumps it out (is drug resistant). The efflux rate of FPAC in the tumor should be proportional the amount of Pgp present and therefore should be a predictor of treatment failure. If this method is successful at identifying MDR, patients can be spared a course of ineffective chemotherapy and can be started on alternative drugs or, if available, an effective MDR modulator can be administered prior to treatment.
In order to validate the biodistribution in non-human primate, 3 normal volunteers will be recruited to participate in a dosimetry PET imaging protocol.
Often, patients with breast cancer are treated with chemotherapy prior to definitive surgical removal of the primary tumor. Three patients with breast cancer who are candidates for this neoadjuvant chemotherapy will also be recruited to participate in this study, in order to demonstrate the feasibility of tumor imaging. As these patients will be receiving chemotherapy (likely paclitaxel), a preliminary correlation with FPAC uptake and tumor response can also be attempted in this pilot study.
Primary Objective
--To obtain human dosimetry and monitor for potential physiologic effects following 4-[F-18] fluoropaclitaxel (FPAC) administration
Secondary Objectives
- a.To characterize tracer uptake in tumors and normal tissues and develop robust methods for analysis of FPAC kinetics in breast tumors
- b.To optimize the imaging protocol for FPAC, and, if feasible, reduce to 1 or 2 static scans
Studietype
Inschrijving (Werkelijk)
Fase
- Vroege fase 1
Contacten en locaties
Studie Locaties
-
-
Virginia
-
Richmond, Virginia, Verenigde Staten, 23298
- Virginia Commonwealth University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Normal Volunteers
Inclusion Criteria:
Subjects must be 18 years or older for inclusion in this study. Because no dosing or adverse event data are currently available on the use of FPAC in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
- All subjects must sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.
- If female, the subject must be postmenopausal for a minimum of one year, or surgically sterile, or be within 14 days of onset of a menstrual period or have a negative beta human chorionic gonadotropin (ßHCG) blood test.
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes >3,000/μL
- absolute neutrophil count >1,500/μL
- platelets >100,000/μL
- total bilirubin within normal institutional limits
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 times the institutional upper limit of normal
- Creatinine within normal institutional limits OR, in subjects with creatinine levels above institutional normal, creatinine clearance >60 mL/min/1.73 m2
Exclusion Criteria:
Subject with a known bleeding disorder
- Subjects who have received chemotherapy within 1 year of entry into study
- Subjects with a history of liver or kidney disease
- Subjects who are receiving any other investigational agents
- Subjects having severe claustrophobia or other condition that would make them unable to lie still for the duration of the study
- Subjects with immunodeficiencies that predispose a subject to specific or non-specific mediator release
- Subjects with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subjects who are pregnant or lactating or who suspect they might be pregnant. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with FPAC, breastfeeding should be discontinued if the mother receives FPAC.
Breast Cancer Patients
Inclusion Criteria:
Subjects must have a history of histologically or cytologically confirmed breast cancer with estimated lesion size of >1cm.
- Subjects must be 18 years or older for inclusion in this study. Because no dosing or adverse event data are currently available on the use of FPAC in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
- All subjects must sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines.
- If female, the subject must be postmenopausal for a minimum of one year, be surgically sterile, be within 14 days of onset of a menstrual period, or have a negative ßHCG blood test.
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes >3,000/μL
- absolute neutrophil count >1,500/μL
- platelets >100,000/μL
- total bilirubin within normal institutional limits
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 times the institutional upper limit of normal
- Creatinine within normal institutional limits OR, in subjects with creatinine levels above institutional normal, creatinine clearance >60 mL/min/1.73 m2
Exclusion Criteria:
•as above
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Imaging feasibility and dosimetry
Tijdsspanne: <6months
|
<6months
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Kalen JD, Hirsch JI, Kurdziel KA, Eckelman WC, Kiesewetter DO. Automated synthesis of 18F analogue of paclitaxel (PAC): [18F]Paclitaxel (FPAC). Appl Radiat Isot. 2007 Jun;65(6):696-700. doi: 10.1016/j.apradiso.2006.10.015. Epub 2006 Dec 11.
- Kurdziel KA, Kalen JD, Hirsch JI, Wilson JD, Agarwal R, Barrett D, Bear HD, McCumiskey JF. Imaging multidrug resistance with 4-[18F]fluoropaclitaxel. Nucl Med Biol. 2007 Oct;34(7):823-31. doi: 10.1016/j.nucmedbio.2007.04.011. Epub 2007 Jul 5.
- Kurdziel KA, Kalen JD, Hirsch JI, Wilson JD, Bear HD, Logan J, McCumisky J, Moorman-Sykes K, Adler S, Choyke PL. Human dosimetry and preliminary tumor distribution of 18F-fluoropaclitaxel in healthy volunteers and newly diagnosed breast cancer patients using PET/CT. J Nucl Med. 2011 Sep;52(9):1339-45. doi: 10.2967/jnumed.111.091587. Epub 2011 Aug 17.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HM03748
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Borstkanker
-
BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
-
Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University en andere medewerkersVoltooidDe klinische toepassingsgids van Conebeam Breast CTChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
-
Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)WervingAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op 4- [F-18] fluoropaclitaxel
-
Chang Gung Memorial HospitalVoltooid
-
Chang Gung Memorial HospitalVoltooidFrontotemporale dementie | Progressieve supranucleaire verlamming | Ziekte van Alzheimer | Vasculaire cognitieve stoornissen | Corticaal basaal syndroomTaiwan
-
Siemens Molecular ImagingFudan UniversityVoltooidHoofd-halskanker | Longkanker | LeverkankerChina
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)VoltooidBaarmoeder Cervicale Neoplasmata | Prostaatneoplasmata | Rectale neoplasmata | Endometriumneoplasmata | Anus NeoplasmataVerenigde Staten
-
Siemens Molecular ImagingVoltooid
-
ABX advanced biochemical compounds GmbHVoltooidProstaatkanker | Prostaatkanker terugkerendFrankrijk
-
Siemens Molecular ImagingVoltooidHoofd-halskanker | LongkankerVerenigde Staten
-
Northwell HealthVoltooidNeuro-endocriene tumorenVerenigde Staten
-
Chang Gung Memorial HospitalVoltooidErnstige depressieve stoornisTaiwan
-
Medical University of ViennaOnbekendDiabetes mellitus type 2Oostenrijk