Study of Dotatate Imaging in Breast Cancer

NCT05880394 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 163-22-CA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

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

  6 months

Interventions

Gallium-68 DOTATATE DRUG

Gallium-68 DOTATATE is a diagnostic agent for use with positron emission tomography (PET) for localization of somatostatin receptor expression on tumors.

Copper-64 DOTATATE DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Irvine, California, 92614, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gary Ulaner, MD, PhD

  Hoag Memorial Hospital Presbyterian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Molecular Imaging and Therapy, Hoag Family Cancer Institute

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: May 30, 2023
• Study Start: January 10, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)