Study of Dotatate Imaging in Breast Cancer (NCT05880394) | Clinical Trial Compass
UnknownPhase 2
Study of Dotatate Imaging in Breast Cancer
United States30 participantsStarted 2023-01-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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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 tr…
What they're measuring
1
Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)