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New imaging trick could sharpen cancer scans
NCT ID NCT07009184
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This early-phase study tests a new imaging agent (TGW211) in 19 adults with HER2-positive solid tumors. The goal is to see if a special 'trigger' can help clear the imaging tracer from healthy tissues faster, making tumor scans clearer. The study focuses on safety and image quality, not treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 19 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed, written informed consent and willing and able to comply with study requirements. 2. Male or Female aged ≥ 18 years. 3. Histologically confirmed HER2-positive cancer (IHC 3+ or IHC 2+ AND FISH+) with at least 1 measurable target lesion of at least 10 mm on CT or MRI based on RECIST v1.1, assessed by the investigator to enable adequate SPECT/CT imaging. 4. WHO performance status (ECOG) of 0 or 1. 5. Adequate organ and bone marrow function, evidenced by the following laboratory results: 1. Absolute neutrophil count ≥ 1.5 x 10\^9 /l; 2. Platelet count ≥ 100 x 10\^9 /l; 3. Hemoglobin ≥ 9.0 g/dl or 5.6 mmol/l; 4. Total bilirubin ≤ 1.5 x the upper limit of normal (ULN); 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases); 6. Serum creatinine ≤ 1.5 x ULN; - Estimated Glomerular Filtration Rate (eGFR)\* ≥ 60 ml/min/1.73 m2 ; \*preferably calculated with CKD-EPI formula. Exclusion Criteria: 1. Medical history of myocardial infarction within 6 months before participation or symptomatic CHF (New York Heart Association Class III to IV). 2. QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec on screening ECG or congenital long QT syndrome. 3. Has a history of (non-infectious) ILD/pneumonitis that required steroids or has current or suspected ILD/pneumonitis. 4. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g, pulmonary embolism within 3 months of trial participation, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.). 5. Has an uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals. 6. Participation in another clinical study with an investigational product during the past 6 weeks. 7. Concurrent enrolment in another clinical study unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study. 8. Pregnant or breastfeeding women, where pregnancy is defined as the time between conception and termination of gestation, confirmed by a positive urinary or serum pregnancy test. 9. Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant and no evidence of post-menopausal status, unless they use highly effective methods of contraception or abstain from sexual activity for 30 days after investigational drug administration. Male partners of female patients should also use a condom during intercourse for 30 days after investigational drug administration to the partner to prevent them from fathering a child. 10. Male patients in the reproductive age, not willing or able to use a condom or abstain from sexual activity for 30 days after investigational drug administration. WOCBP partners of sexually active male patients should also use a highly effective contraception method during intercourse for 30 days after investigational drug administration of the partner. 11. Known allergy or hypersensitivity to any of the investigational drugs or its excipients. 12. Any condition which, in the opinion of the investigator, would preclude participation in the study. 13. Second active malignancy.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Radboud University Medical Center
RECRUITINGNijmegen, Gelderland, 6525 GS, Netherlands
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