SPECT/CT Imaging of Gastrin-releasing Peptide Receptor Expression in Breast Cancer With Different Estrogen Receptor Expression Using Technetium-99m-labelled DB8 [99mTc]Tc-DB8
Trial Snapshot
- Phase
- Phase 2
- Status
- Enrolling By Invitation
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- [99mTc]Tc-DB8 background uptake value
Study Overview
Brief Summary
The study should evaluate the [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.
Detailed Description
The aim of the study is to determine gastrin-releasing peptide receptor expression in primary breast cancer patients with positive and negative estrogen receptor expression before any systemic or local treatment.
Phase II. Assessment of [99mTc]Tc-DB8 accumulation in primary tumors with positive and negative estrogen receptor expression in breast cancer patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is > 18 years of age
- •Availability of results from estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor
- •Hematological, liver and renal function test results within the following limits:
- •White blood cell count: > 2.0 x 109/L
- •Hemoglobin: > 80 g/L
- •Platelets: > 50.0 x 109/L
- •ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
- •Bilirubin =< 2.0 times Upper Limit of Normal
- •Serum creatinine: Within Normal Limits
- •A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
- •Subject is capable to undergo the diagnostic investigations to be performed in the study
- •Informed consent
Exclusion Criteria
- •Any system therapy (chemo-/targeted therapy)
- •Second, non-breast malignancy
- •Active current autoimmune disease or history of autoimmune disease
- •Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
- •Known HIV positive or chronically active hepatitis B or C
- •Administration of other investigational medicinal product within 30 days of screening
- •Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Arms & Interventions
Breast cancer patients with positive estrogen receptor expression
Assessment of [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive estrogen receptor expression.
Intervention: [99mTc]Tc-DB8 (Drug)
Breast cancer patients with negative estrogen receptor expression
Assessment of [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with negative estrogen receptor expression.
Intervention: [99mTc]Tc-DB8 (Drug)
Outcomes
Primary Outcomes
[99mTc]Tc-DB8 background uptake value
Time Frame: 2 hours
SPECT/CT-based \[99mTc\]Tc-DB8 background uptake value (SUVmax)
Tumor-to-background ratio (SPECT/CT)
Time Frame: 2 hours
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DB8 uptake coinciding with the regions without pathological findings (SUVmax)
[99mTc]Tc-DB8 uptake in primary breast tumor
Time Frame: 2 hours
SPECT/СT-based \[99mTc\]Tc-DB8 uptake in primary breast tumor with positive and negative estrogen receptor expression (SUVmax)
Secondary Outcomes
- Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake(2 hours)