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Informações:
Falhas:
ID
26309
Descrição
Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT; ODM derived from: https://clinicaltrials.gov/show/NCT00725946
Link
https://clinicaltrials.gov/show/NCT00725946
Palavras-chave
Versões (2)
- 16/10/2017 16/10/2017 -
- 20/09/2021 20/09/2021 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
16 de outubro de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00725946
Eligibility Breast Cancer NCT00725946
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00725946
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
C0019928 (UMLS CUI [4])
C0005515 (UMLS CUI [5])
C1096666 (UMLS CUI [2])
C0304497 (UMLS CUI [3])
C0019928 (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])
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])
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])
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])
C2024776 (UMLS CUI [2])