Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT02742168
Eligibility Criteria:
Diagnostic group：
Inclusion Criteria:
* Males and females, ≥20 years old.
* Part of lesion CT and/or 18F-FDG PET/CT and/or MRI and/or Doppler Ultrasound and/or Mammography diagnosis in suspicion of primary or recurrent breast cancer.
* The above cancers will be histologically confirmed or results of histology will be available.
Exclusion Criteria:
* Females planning to bear a child recently or with childbearing potential.
* Known severe allergy.
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia,radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
Efficacy evaluation group:
Inclusion Criteria:
* Males and females, ≥20 years old.
* Firstly and definitely diagnose with malignant tumors ,and prepare to chemotherapy (including neoadjuvant chemotherapy) or radiotherapy.
* There are available lesions for assessment during the trial.
* Part of lesion CT and/or 18F-FDG PET/CT and/or MRI and/or Doppler Ultrasound and/or Mammography examination before treatment, the mid tern treatment, post-treatment( three months after the initial treatment) are available.
Exclusion Criteria:
* Females planning to bear a child recently or with childbearing potential.
* Known severe allergy or hypersensitivity to IV radiographic contrast.
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02742168
Study Brief:
Protocol Section:
NCT02742168