ID

36571

Description

A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01615406

Link

https://clinicaltrials.gov/show/NCT01615406

Keywords

Versions (3)
  1. 1/17/19 1/17/19 -
  2. 5/22/19 5/22/19 -
  3. 5/23/19 5/23/19 - Sarah Riepenhausen
Copyright Holder

Molecular Insight Pharmaceuticals, Inc.

Uploaded on

May 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Comparing 99mTc-MIP-1404 SPECT/CT to Histology in Prostate Cancer NCT01615406

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male aged 21 years or older
Description

Gender and Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
ability to provide signed informed consent and willingness to comply with protocol requirements.
Description

Informed consent and compliance with protocol requirements

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
past biopsy indicating the presence of adenocarcinoma of the prostate gland
Description

past biopsy indicating the presence of adenocarcinoma of the prostate gland

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0005558
participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
Description

participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection

Data type

boolean

Alias
UMLS CUI [1,1]
C0040300
UMLS CUI [1,2]
C0242114
UMLS CUI [1,3]
C0600139
UMLS CUI [1,4]
C3900053
UMLS CUI [1,5]
C0005558
UMLS CUI [2,1]
C0040300
UMLS CUI [2,2]
C0242114
UMLS CUI [2,3]
C0600139
UMLS CUI [2,4]
C3900053
UMLS CUI [2,5]
C0728940
have had, or will undergo diagnostic CT or MRI imaging prior to surgery
Description

diagnostic CT or MRI prior to surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0040405
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0543467
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C0011923
UMLS CUI [2,3]
C0917711
UMLS CUI [2,4]
C0332152
UMLS CUI [2,5]
C0543467
UMLS CUI [3,1]
C0205156
UMLS CUI [3,2]
C0011923
UMLS CUI [3,3]
C0040405
UMLS CUI [3,4]
C0332152
UMLS CUI [3,5]
C0543467
UMLS CUI [4,1]
C0205156
UMLS CUI [4,2]
C0011923
UMLS CUI [4,3]
C0917711
UMLS CUI [4,4]
C0332152
UMLS CUI [4,5]
C0543467
participants must agree to use an acceptable form of birth control throughout the study period. participants must use condoms for a period of seven days after study drug administration, if engaged in sexual activity.
Description

Agreeing to acceptable birth control throughout study and using condoms after study drug administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C2347804
UMLS CUI [1,3]
C3641827
UMLS CUI [2,1]
C0679782
UMLS CUI [2,2]
C0580203
UMLS CUI [2,3]
C3469597
UMLS CUI [2,4]
C0304229
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants for whom participating would significantly delay the scheduled standard of care therapy
Description

Participating would significantly delay the scheduled standard of care therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0205421
UMLS CUI [1,4]
C2936643
participants administered a radioisotope within 5 physical half lives prior to study enrollment
Description

Recent administration of radioisotope

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0034595
UMLS CUI [2]
C0259911
participants with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
Description

Medical condition or other circumstances impeding obtaining reliable data, achieving study objectives or completing study

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3858758
UMLS CUI [1,4]
C0681873
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2985627
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2348577
UMLS CUI [4,1]
C0680082
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C3858758
UMLS CUI [4,4]
C0681873
UMLS CUI [5,1]
C0680082
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C2985627
UMLS CUI [6,1]
C0680082
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C2348577
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender and Age
Item
male aged 21 years or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed consent and compliance with protocol requirements
Item
ability to provide signed informed consent and willingness to comply with protocol requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
past biopsy indicating the presence of adenocarcinoma of the prostate gland
Item
past biopsy indicating the presence of adenocarcinoma of the prostate gland
boolean
C0007112 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection
Item
participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
boolean
C0040300 (UMLS CUI [1,1])
C0242114 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C3900053 (UMLS CUI [1,4])
C0005558 (UMLS CUI [1,5])
C0040300 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C3900053 (UMLS CUI [2,4])
C0728940 (UMLS CUI [2,5])
diagnostic CT or MRI prior to surgery
Item
have had, or will undergo diagnostic CT or MRI imaging prior to surgery
boolean
C1301732 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,5])
C1301732 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C0917711 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0543467 (UMLS CUI [2,5])
C0205156 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0543467 (UMLS CUI [3,5])
C0205156 (UMLS CUI [4,1])
C0011923 (UMLS CUI [4,2])
C0917711 (UMLS CUI [4,3])
C0332152 (UMLS CUI [4,4])
C0543467 (UMLS CUI [4,5])
Agreeing to acceptable birth control throughout study and using condoms after study drug administration
Item
participants must agree to use an acceptable form of birth control throughout the study period. participants must use condoms for a period of seven days after study drug administration, if engaged in sexual activity.
boolean
C0700589 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
C0679782 (UMLS CUI [2,1])
C0580203 (UMLS CUI [2,2])
C3469597 (UMLS CUI [2,3])
C0304229 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Participating would significantly delay the scheduled standard of care therapy
Item
participants for whom participating would significantly delay the scheduled standard of care therapy
boolean
C2348568 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0205421 (UMLS CUI [1,3])
C2936643 (UMLS CUI [1,4])
Recent administration of radioisotope
Item
participants administered a radioisotope within 5 physical half lives prior to study enrollment
boolean
C0332185 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0034595 (UMLS CUI [1,3])
C0259911 (UMLS CUI [2])
Medical condition or other circumstances impeding obtaining reliable data, achieving study objectives or completing study
Item
participants with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3858758 (UMLS CUI [1,3])
C0681873 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2985627 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2348577 (UMLS CUI [3,3])
C0680082 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C3858758 (UMLS CUI [4,3])
C0681873 (UMLS CUI [4,4])
C0680082 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C2985627 (UMLS CUI [5,3])
C0680082 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C2348577 (UMLS CUI [6,3])
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