Study of Dotatate Imaging in Breast Cancer

NCT ID: NCT05880394

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-07-31

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.

Conditions

Breast Cancer Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Gallium-68 DOTATATE

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

Copper-64 DOTATATE

Copper-64 DOTATATE is a diagnostic agent for use with positron emission tomography (PET) for localization of somatostatin receptor expression on tumors.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role: lead

Responsible Party

Gary Ulaner

Director of Molecular Imaging and Therapy, Hoag Family Cancer Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Ulaner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hoag Memorial Hospital Presbyterian

Locations

Hoag Memorial Hospital Presbyterian

Irvine, California, United States

Countries

United States

Other Identifiers

163-22-CA

Identifier Type: -

Identifier Source: org_study_id