[99mTc]Tc-DB8 Accumulation in Primary Tumor in Breast Cancer With Positive and Negative Estrogen Receptor Expression
NCT ID: NCT07275463
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
40 participants
INTERVENTIONAL
2025-10-01
2026-12-31
Brief Summary
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Detailed Description
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Phase II. Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumors with positive and negative estrogen receptor expression in breast cancer patients.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
[99mTc]Tc-DB8
One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection
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.
[99mTc]Tc-DB8
One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection
Interventions
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[99mTc]Tc-DB8
One single injection of \[99mTc\]Tc-DB8, followed by SPECT/CT imaging 2 hours after the injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Availability of results from estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor
3. 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
4. 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
5. Subject is capable to undergo the diagnostic investigations to be performed in the study
6. Informed consent
Exclusion Criteria
2. Second, non-breast malignancy
3. Active current autoimmune disease or history of autoimmune disease
4. 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
5. Administration of other investigational medicinal product within 30 days of screening
6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
18 Years
80 Years
FEMALE
No
Sponsors
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Uppsala University
OTHER
Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Vladimir I Chernov, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Tomsk NRMC
Locations
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Russia Tomsk NRMC
Tomsk, , Russia
Countries
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Other Identifiers
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Molecular imaging of GRPR
Identifier Type: -
Identifier Source: org_study_id