The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in… (NCT06199453) | Clinical Trial Compass
WithdrawnPhase 2
The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial
Stopped: Administrative reasons
Poland0Started 2024-01
Plain-language summary
Non-commercial phase 2 clinical trial to evaluate the effectiveness, safety and tolerability of treatment using prostate-specific membrane antigen (PSMA) labeled with 177Lutetium in patients with recurrence and/or metastases in adenoid cystic carcinoma originating from the salivary glands of the head and neck region.
Patients with PSMA receptor expression confirmed by PET/CT after administration of 68Ga-PSMA I\&T will be eligible for treatment.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Signing the informed consent form to participate in the study
* Patients with inoperable, locoregionally advanced or metastatic, histopathologically confirmed adenoid cystic carcinoma of salivary gland
* Age over 18 years
* WHO performance status 0 to 2
* PSMA expression confirmed by PET/CT using 68Ga-PSMA;
* Presence of measurable disease according to RECIST 1.1 criteria
* Adequate function of: bone marrow, liver, kidneys:
bone marrow: neutrophils \>1500x10\^9/L; thrombocytes \>150,000x10\^9/L, hemoglobin \>9 g/dl liver: bilirubin \<2xULN; aminotransferases \<3xULN (in patients with liver metastases \<5xULN) kidney: eGFR \>50 ml/min albumin \>2.5 mg/ml
* For women of reproductive age: confirmed negative pregnancy test
* The need to use of a highly effective method of contraception
Exclusion criteria:
* Pregnancy or breastfeeding
* Lack of effective contraception during childbearing age
* Patients with metastases to the brain, meninges or heart
* Severe or significant additional diseases in the opinion of the investigator
* Urinary tract obstruction and/or hydronephrosis.
* Concomitant treatment of another cancer
* Myelosuppressive or nuclear treatment later than 4 weeks after qualification
* Previous treatment with 177Lutetium-labeled PSMA
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
Assessment of the effectiveness of the study treatment
Timeframe: 2 years after the end of treatment
Trial details
NCT IDNCT06199453
SponsorMaria Sklodowska-Curie National Research Institute of Oncology