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Study of Dotatate Imaging in Breast Cancer

Primary Purpose

Breast Cancer Stage IV

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gallium-68 DOTATATE
Copper-64 DOTATATE
Sponsored by
Hoag Memorial Hospital Presbyterian
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer Stage IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hoag Memorial Hospital Presbyterian

Outcomes

Primary Outcome Measures

Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)

Secondary Outcome Measures

Full Information

First Posted
February 24, 2023
Last Updated
September 25, 2023
Sponsor
Hoag Memorial Hospital Presbyterian
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1. Study Identification

Unique Protocol Identification Number
NCT05880394
Brief Title
Study of Dotatate Imaging in Breast Cancer
Official Title
Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hoag Memorial Hospital Presbyterian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stage IV

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gallium-68 DOTATATE
Intervention 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(s)
Copper-64 DOTATATE
Intervention Description
Copper-64 DOTATATE is a diagnostic agent for use with positron emission tomography (PET) for localization of somatostatin receptor expression on tumors.
Primary Outcome Measure Information:
Title
Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Ulaner, MD, PhD
Organizational Affiliation
Hoag Memorial Hospital Presbyterian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Dotatate Imaging in Breast Cancer

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