[99mTc]Tc-DB8 Accumulation in Primary Tumor in Breast Cancer With Positive and Negative Estrogen Receptor Expression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [99mTc]Tc-DB8.
- Who it may be relevant to
- Registry conditions: Primary Breast Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug [99mTc]Tc-DB8
One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection
Primary outcome measures
- [99mTc]Tc-DB8 uptake in primary breast tumor [Time frame: 2 hours]
- [99mTc]Tc-DB8 background uptake value [Time frame: 2 hours]
- Tumor-to-background ratio (SPECT/CT) [Time frame: 2 hours]
Secondary outcome measures (1)
- Estrogen receptor positive vs estrogen receptor negative [99mTc]Tc-DB8 uptake [Time frame: 2 hours]
Eligibility criteria
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) 4. 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Russia · 1 center
- Russia Tomsk NRMC — Tomsk
Identifiers
NCT: NCT07275463 · ORI-15/09/2023-1