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Trial Title:
Study of Dotatate Imaging in Breast Cancer
NCT ID:
NCT05880394
Condition:
Breast Cancer Stage IV
Conditions: Official terms:
Breast Neoplasms
Copper
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gallium-68 DOTATATE
Description:
Gallium-68 DOTATATE is a diagnostic agent for use with positron emission tomography (PET)
for localization of somatostatin receptor expression on tumors.
Intervention type:
Drug
Intervention name:
Copper-64 DOTATATE
Description:
Copper-64 DOTATATE is a diagnostic agent for use with positron emission tomography (PET)
for localization of somatostatin receptor expression on tumors.
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.
Detailed description:
Subjects with metastatic breast cancer are planned to be enrolled to undergo Gallium-68
DOTATATE or Copper-64 DOTATATE PET/CT imaging at one time point. SSTR uptake in
metastatic lesions will be evaluated by independent central review (ICR). FDG PET and
bone scans will also be performed within +/- 3 weeks of DOTATATE imaging.
The primary objective of this study is to evaluate uptake of Gallium-68 DOTATATE or
Copper-64 DOTATATE in metastatic ER+ breast cancer lesions.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hoag Memorial Hospital Presbyterian
Address:
City:
Irvine
Zip:
92614
Country:
United States
Start date:
January 10, 2023
Completion date:
July 31, 2024
Lead sponsor:
Agency:
Hoag Memorial Hospital Presbyterian
Agency class:
Other
Source:
Hoag Memorial Hospital Presbyterian
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05880394
