ID

43886

Descrizione

Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT; ODM derived from: https://clinicaltrials.gov/show/NCT00725946

collegamento

https://clinicaltrials.gov/show/NCT00725946

Keywords

versioni (2)
  1. 16/10/17 16/10/17 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

20 settembre 2021

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00725946

Inglese

Eligibility Breast Cancer NCT00725946

1 moduli  
Criteria
Descrizione

Criteria

2. criteria for nis-positivity are defined as: >= 20% of cells with plasma membrane and/or strong intracellular/plasma membrane immunoreactivity 3. any previous therapy including radiation therapy is allowable. 4. women 18 years of age or older. 5. patients must have a life expectancy of at least 3 months 6. patients with ecog performance status 0-3 will be eligible. 7. if on chemotherapy, thyroid suppression should be initiated no sooner than two weeks after last chemotherapy cycle.
Descrizione

Criteria Sodium-iodide symporter Positive | Cells Percentage Plasma membrane Immunoreactivity | Intracellular Plasma membrane Immunoreactivity | Therapeutic radiology procedure | Gender | Age | Life Expectancy | ECOG performance status | Chemotherapy | Thyroid stimulating hormone suppression therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0142963
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0007603
UMLS CUI [2,4]
C0597879
UMLS CUI [3,1]
C0178719
UMLS CUI [3,2]
C0007603
UMLS CUI [3,3]
C0597879
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0079399
UMLS CUI [6]
C0001779
UMLS CUI [7]
C0023671
UMLS CUI [8]
C1520224
UMLS CUI [9]
C0392920
UMLS CUI [10]
C3875303
8. ability to understand and willingness to sign a written informed consent document.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
9. discontinuation of hormonal or biological therapies for the 10 days of the study is preferred but not mandated.
Descrizione

Hormone Therapy Discontinuation | Biological treatment Discontinuation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1444662
10. laboratory tests (cbc, comprehensive metabolic panel) must be performed within 120 day prior to study initiation.
Descrizione

Laboratory Procedures | Complete Blood Count | Comprehensive metabolic panel

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0009555
UMLS CUI [3]
C0519825
exclusion criteria:1. history of metastatic thyroid cancer 2. exclude the use of cytotoxic, hormonal or biological agents for one week prior to and during imaging.
Descrizione

Exclusion Criteria | Thyroid cancer metastatic | Cytotoxic agent | Hormone preparation | Biologic agents

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1096666
UMLS CUI [3]
C0304497
UMLS CUI [4]
C0019932
UMLS CUI [5]
C0005515
3. pregnant or nursing patients will be excluded from the study as iodide can accumulate in the breast and is transported across the placenta.
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. inability to tolerate thyroid hormone and/or methimazole pre-imaging treatment.
Descrizione

Intolerance to Thyroid Hormones | Intolerance to Methimazole

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0040135
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025644
5. history of thyroid cancer (because patient could have concomitant thyroid cancer metastases and therefore competitively concentrate radioiodides) 6. psychiatric or addictive disorders that are not adequately controlled and would preclude obtaining informed consent.
Descrizione

Thyroid carcinoma | Mental disorders Uncontrolled Exclude Informed Consent | Addictive Behavior Uncontrolled Excludes Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0549473
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0021430
UMLS CUI [3,1]
C0085281
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0332196
UMLS CUI [3,4]
C0021430
7. patients with heart disease or other significant cardiac risk factors will be excluded from receiving thyroid suppressive therapy so as to avoid precipitating a cardiac arrhythmia.
Descrizione

Heart Disease | cardiac risk factors

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C2024776
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Similar models

Eligibility Breast Cancer NCT00725946

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Criteria Sodium-iodide symporter Positive | Cells Percentage Plasma membrane Immunoreactivity | Intracellular Plasma membrane Immunoreactivity | Therapeutic radiology procedure | Gender | Age | Life Expectancy | ECOG performance status | Chemotherapy | Thyroid stimulating hormone suppression therapy
Item
2. criteria for nis-positivity are defined as: >= 20% of cells with plasma membrane and/or strong intracellular/plasma membrane immunoreactivity 3. any previous therapy including radiation therapy is allowable. 4. women 18 years of age or older. 5. patients must have a life expectancy of at least 3 months 6. patients with ecog performance status 0-3 will be eligible. 7. if on chemotherapy, thyroid suppression should be initiated no sooner than two weeks after last chemotherapy cycle.
boolean
C0243161 (UMLS CUI [1,1])
C0142963 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0007634 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0007603 (UMLS CUI [2,3])
C0597879 (UMLS CUI [2,4])
C0178719 (UMLS CUI [3,1])
C0007603 (UMLS CUI [3,2])
C0597879 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0001779 (UMLS CUI [6])
C0023671 (UMLS CUI [7])
C1520224 (UMLS CUI [8])
C0392920 (UMLS CUI [9])
C3875303 (UMLS CUI [10])
Informed Consent
Item
8. ability to understand and willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Hormone Therapy Discontinuation | Biological treatment Discontinuation
Item
9. discontinuation of hormonal or biological therapies for the 10 days of the study is preferred but not mandated.
boolean
C0279025 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Laboratory Procedures | Complete Blood Count | Comprehensive metabolic panel
Item
10. laboratory tests (cbc, comprehensive metabolic panel) must be performed within 120 day prior to study initiation.
boolean
C0022885 (UMLS CUI [1])
C0009555 (UMLS CUI [2])
C0519825 (UMLS CUI [3])
Exclusion Criteria | Thyroid cancer metastatic | Cytotoxic agent | Hormone preparation | Biologic agents
Item
exclusion criteria:1. history of metastatic thyroid cancer 2. exclude the use of cytotoxic, hormonal or biological agents for one week prior to and during imaging.
boolean
C0680251 (UMLS CUI [1])
C1096666 (UMLS CUI [2])
C0304497 (UMLS CUI [3])
C0019932 (UMLS CUI [4])
C0005515 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
3. pregnant or nursing patients will be excluded from the study as iodide can accumulate in the breast and is transported across the placenta.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Intolerance to Thyroid Hormones | Intolerance to Methimazole
Item
4. inability to tolerate thyroid hormone and/or methimazole pre-imaging treatment.
boolean
C1744706 (UMLS CUI [1,1])
C0040135 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0025644 (UMLS CUI [2,2])
Thyroid carcinoma | Mental disorders Uncontrolled Exclude Informed Consent | Addictive Behavior Uncontrolled Excludes Informed Consent
Item
5. history of thyroid cancer (because patient could have concomitant thyroid cancer metastases and therefore competitively concentrate radioiodides) 6. psychiatric or addictive disorders that are not adequately controlled and would preclude obtaining informed consent.
boolean
C0549473 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
C0085281 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0021430 (UMLS CUI [3,4])
Heart Disease | cardiac risk factors
Item
7. patients with heart disease or other significant cardiac risk factors will be excluded from receiving thyroid suppressive therapy so as to avoid precipitating a cardiac arrhythmia.
boolean
C0018799 (UMLS CUI [1])
C2024776 (UMLS CUI [2])
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