Breast Cancer Stage IV Clinical Trial
Official title:
Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
Verified date | February 2024 |
Source | Hoag Memorial Hospital Presbyterian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age of at least 18 years at the time of signing the informed consent. - Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging. - For women of childbearing potential (WOCBP): a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (= 12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug). - Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence. Exclusion Criteria: - Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE - Current high-dose glucocorticoid (= 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours. - Unable to perform PET/CT scans according to technical specifications and local guidelines. - Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study. - Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. - Unable or unwilling to comply with the requirements of the study protocol. - Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan. |
Country | Name | City | State |
---|---|---|---|
United States | Hoag Memorial Hospital Presbyterian | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
Hoag Memorial Hospital Presbyterian |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV) | 6 months |
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