ID

38463

Description

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

Link

https://clinicaltrials.gov/show/NCT01420146

Keywords

Versions (1)
  1. 10/20/19 10/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01420146

English

Eligibility Breast Neoplasms NCT01420146

1 forms  
Inclusion Criteria
Description

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).
Description

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

Data type

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.
Description

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

Data type

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.
Description

Metastatic Lesion Positive FDG-PET

Data type

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.
Description

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

Data type

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.
Description

Metastatic site Biopsy Planned | HER2 Status Control

Data type

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
Description

Age

Data type

boolean

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

ECOG performance status

Data type

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.
Description

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

Data type

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.
Description

Agreement imaging study | Lesion Quantity Biopsy

Data type

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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

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

Severe allergy Trastuzumab

Data type

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
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

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
Description

Secondary malignant neoplasm of bone only

Data type

boolean

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

Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

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.
Description

lapatinib | Status pre- Immunotherapy PET-CT

Data type

boolean

Alias
UMLS CUI [1]
C1506770
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C1699633
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Similar models

Eligibility Breast Neoplasms NCT01420146

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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