Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3 (NCT05923177) | Clinical Trial Compass
CompletedPhase 1
Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3
Russia10 participantsStarted 2023-09-01
Plain-language summary
The study should evaluate distribution of \[123I\] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is \> 18 years of age
. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
. Hematological, liver and renal function test results within the following 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gamma camera-based whole-body [123I] I-(HE)3-G3 uptake value (%)
Timeframe: 6 hours
2
SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [123I] I-(HE)3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Timeframe: 6 hours
3
SPECT-based [123I] I-(HE)3-G3 background uptake value (counts)
Timeframe: 6 hours
4
Tumor-to-background ratio (SPECT)
Timeframe: 6 hours
Trial details
NCT IDNCT05923177
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
. 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