Positronemissionstomografi hos kvinnor med avancerad HER2-positiv bröstcancer
64 Cu-DOTA-Trastuzumab Positron Emission Tomografi hos kvinnor med avancerad HER2 positiv invasiv bröstcancer
RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment
PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer.
II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease.
III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.
OUTLINE:
This is a part one dose-determining study followed by a part two study. PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab at the optimal dose as determined in part one of the study.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Eligibility Part I (Determination of the cold dose)
- Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
- At least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
- The cancer must over express HER2 as determined by IHC and FISH.
- Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
- Participants must have normal cardiac ejection fraction.
Eligibility Part 2 (correlation of HER2 expression with PET uptake)
- Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
- At least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
- Participants with HER2 1+, 2+ and 3+ by IHC are eligible.
- Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
- Participants must have normal cardiac ejection fraction.
Ineligibility
- Participants who have received trastuzumab within the prior 2 months
- Participants who are not considered candidates for trastuzumab
- Metastatic disease in a single site
- No metastatic site greater than or equal to 2 cm
- Concurrent malignancy other than skin cancer
- Inability to provide informed consent
- Participants who are pregnant
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm I
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. |
Correlative studies PET images performed on a GE Discovery 16 Ste PET-CT scanner
Andra namn:
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
Andra namn:
Correlative Studies
Andra namn:
Correlative studies
Andra namn:
Correlative studies |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
Tidsram: 24 hours after injection of 64 CU-DOTA-trastuzumab
|
Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). |
24 hours after injection of 64 CU-DOTA-trastuzumab
|
|
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours
Tidsram: 48 hours after injection of 64 CU-DOTA-trastuzumab
|
Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan). |
48 hours after injection of 64 CU-DOTA-trastuzumab
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Joanne Mortimer, City of Hope Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Undersökningstekniker
- Provhantering
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Kirurgiska ingrepp, operativ
- Cytologiska tekniker
- Cytodiagnos
- Diagnostiska tekniker, kirurgiska
- Kemitekniker, analytiska
- Spektrumanalys
- Histocytokemi
- Histologiska tekniker
- Immunologiska tekniker
- Biopsi
- Magnetresonansspektroskopi
- Immunohistokemi
- 2-fenyl-6- (2 '-(4'-(etoxikarbonyl) tiazolyl)) tiazolo (3,2-b) (1,2,4) triazol
- 64Cu-DOTA-trastuzumab
Andra studie-ID-nummer
- 09101
- NCI-2010-00322 (Registeridentifierare: NCI CTRP)
- BC095002 (Annat bidrag/finansieringsnummer: Department of Defense)
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