ID

38463

Descrizione

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01420146

collegamento

https://clinicaltrials.gov/show/NCT01420146

Keywords

versioni (1)
  1. 20/10/19 20/10/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

20 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Breast Neoplasms NCT01420146

Inglese

Eligibility Breast Neoplasms NCT01420146

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced her2 positive breast cancer (this includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).
Descrizione

Imaging study | Therapy Advanced breast cancer HER2 Positive | trastuzumab | Chemotherapy | Hormone Therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1881134
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3495917
UMLS CUI [2,3]
C2348909
UMLS CUI [3]
C0728747
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0279025
2. histologically confirmed her 2 positive (defined as fish amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.
Descrizione

Invasive carcinoma of breast HER2 Positive | HER2 gene amplification Fluorescent in Situ Hybridization | Recurrent disease Locally | Neoplasm Metastasis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0162789
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C1517927
UMLS CUI [4]
C0027627
3. patients with fdg-pet positive metastatic lesions.
Descrizione

Metastatic Lesion Positive FDG-PET

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C3641247
4. brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
Descrizione

Metastatic malignant neoplasm to brain Controlled | Absence Metastatic cancer site Solitary

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C2911690
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0280457
UMLS CUI [2,3]
C0205171
5. patient planned to have metastatic site biopsy for her2 status control.
Descrizione

Metastatic site Biopsy Planned | HER2 Status Control

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0280457
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1512413
UMLS CUI [2,2]
C0243148
6. age ≥ 18 years
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
7. eastern cooperative oncology group (ecog) performance status (ps) 0 to 1
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
8. for women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
Descrizione

Childbearing Potential Pregnancy Test | Childbearing Potential Contraceptive methods | Exception Hormonal contraception

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2985296
9. agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
Descrizione

Agreement imaging study | Lesion Quantity Biopsy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C1881134
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0005558
10. signed written informed consent (approved by the ethics committee) obtained prior to any study procedure
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
Descrizione

Systemic disease Severe Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0025517
2. pregnant or lactating women
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. current known infection with hiv, hbv, or hcv
Descrizione

HIV Infection | Hepatitis B | Hepatitis C

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
4. known severe hypersensitivity to trastuzumab
Descrizione

Severe allergy Trastuzumab

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0728747
5. assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Descrizione

Protocol Compliance Unable | Protocol Compliance Unwilling

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
6. patients with bone only metastases are not eligible
Descrizione

Secondary malignant neoplasm of bone only

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0205171
7. psychiatric illness/social situations that would limit compliance with study requirements
Descrizione

Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
8. patients who received lapatinib within the 7 days prior to her immunopet/ct.
Descrizione

lapatinib | Status pre- Immunotherapy PET-CT

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1506770
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C1699633
Ritorna all'inizio della pagina

Similar models

Eligibility Breast Neoplasms NCT01420146

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Imaging study | Therapy Advanced breast cancer HER2 Positive | trastuzumab | Chemotherapy | Hormone Therapy
Item
1. all patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced her2 positive breast cancer (this includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).
boolean
C1881134 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3495917 (UMLS CUI [2,2])
C2348909 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
Invasive carcinoma of breast HER2 Positive | HER2 gene amplification Fluorescent in Situ Hybridization | Recurrent disease Locally | Neoplasm Metastasis
Item
2. histologically confirmed her 2 positive (defined as fish amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.
boolean
C0853879 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4])
Metastatic Lesion Positive FDG-PET
Item
3. patients with fdg-pet positive metastatic lesions.
boolean
C1513183 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Controlled | Absence Metastatic cancer site Solitary
Item
4. brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
boolean
C0220650 (UMLS CUI [1,1])
C2911690 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0280457 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Metastatic site Biopsy Planned | HER2 Status Control
Item
5. patient planned to have metastatic site biopsy for her2 status control.
boolean
C0280457 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1512413 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
Age
Item
6. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status (ps) 0 to 1
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Pregnancy Test | Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
8. for women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2985296 (UMLS CUI [3,2])
Agreement imaging study | Lesion Quantity Biopsy
Item
9. agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
boolean
C0680240 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
Informed Consent
Item
10. signed written informed consent (approved by the ethics committee) obtained prior to any study procedure
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic disease Severe Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease
Item
1. current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Infection | Hepatitis B | Hepatitis C
Item
3. current known infection with hiv, hbv, or hcv
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Severe allergy Trastuzumab
Item
4. known severe hypersensitivity to trastuzumab
boolean
C2945656 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
5. assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Secondary malignant neoplasm of bone only
Item
6. patients with bone only metastases are not eligible
boolean
C0153690 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
7. psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
lapatinib | Status pre- Immunotherapy PET-CT
Item
8. patients who received lapatinib within the 7 days prior to her immunopet/ct.
boolean
C1506770 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C1699633 (UMLS CUI [2,3])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial