New PET scan agent could spot bladder cancer earlier
NCT ID NCT04897763
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new imaging agent called 89Zr-girentuximab in 6 people with non-muscle-invasive bladder cancer. The goal was to see if it could safely and clearly show tumors on PET/CT scans. Researchers looked for uptake spots in the bladder and checked for side effects up to 30 days after injection.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
6 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
Sep 2022
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Female or male, Age ≥ 18 years at time of study entry. * Performance Status: 0 or 1. * Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumors. * Histologically-confirmed pTa Grade 3 or pT1 Grade 3 bladder cancer patients relapsing without muscle invasion. * Negative sterile Urine cytobacteriological testing at baseline (T0). * Consent to use a contraception method for at least 30 days after administration of 89Zr-girentuximab. * Patient has valid health insurance. Exclusion Criteria: * Patient with urinary incontinence. * Known hypersensitivity to girentuximab. * Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of 89Zr-girentuximab * Exposure to any radiopharmaceutical within 30 days (corresponding to 10 half-lives of Zr-89) prior to the administration of 89Zr-girentuximab * Patients suffering from a bladder cancer at stage pT2, pT3 or pT4 * Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient; as judged by the investigator * Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma * Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of 89Zr-girentuximab administration * Patients with known human immunodeficiency viruses (HIV), Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) infections, * Pregnant or likely to be pregnant or nursing patient. * Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study * Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bladder cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institut de cancerologie de l'Ouest
Saint-Herblain, 44805, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dutch bladder cancer cohort aims to map survival and recurrence
- Can two drugs plus chemoradiation let bladder cancer patients keep their bladder?
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?