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The evaluation of the effectiveness, safety and tolerability of treatment, using a specialized prostate-specific membrane antigen (PSMA) labeled with Lutetium177, in patients with recurrent and/or metastatic adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial
EU CTIS ID: 2023-504699-73-00
What this study is testing
Assessment of safety and tolerability of treatment according to Common Terminology Criteria for Adverse Events (CTCAE v. 5.0)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Giving written informed consent to participate in the study.
- Patients with unresectable, locoregionally advanced or metastatic, histopathologically proven Adenoid Cystic Carcinoma of salivary glands.
- Age over 18 years.
- WHO Performance Status 0 to 2.
- 68Ga-PSMA PET/CT proven expression of PSMA; a positive result is considered as a qualitative assessment equal or greater than accumulation in functional liver.
- Progression of disease confirmed by imaging scans according to RECIST 1.1 criteria.
You likely can't join if
- Pregnancy or breastfeeding.
- Lack of effective contraception in childbearing age.
- Patients with brain, cerebral meninges or heart metastases.
- Severe or significant concomitant disease in the investigator's assessment.
- Urinary tract obstruction or/and hydronephrosis.
- Concurrent anticancer treatment.
See the full eligibility criteria
- Giving written informed consent to participate in the study.
- Patients with unresectable, locoregionally advanced or metastatic, histopathologically proven Adenoid Cystic Carcinoma of salivary glands.
- Age over 18 years.
- WHO Performance Status 0 to 2.
- 68Ga-PSMA PET/CT proven expression of PSMA; a positive result is considered as a qualitative assessment equal or greater than accumulation in functional liver.
- Progression of disease confirmed by imaging scans according to RECIST 1.1 criteria.
- Adequate function of: Bone marrow - neutrophils >1500x109/L; thrombocytes >150 000x109/L, hemoglobin >9 g/dl; Liver - bilirubin <2xULN (upper limit of normal range); aminotransferase <3xULN (patients with liver metastases <5xULN); Kidneys - eGFR >50 ml/min; Albumins >2,5 mg/ml
- In women with procreative ability: confirmed negative pregnancy test result and consent to the implementation of double barrier contraception method.
- In men with procreative ability: consent to the implementation of double barrier contraception method.
- Pregnancy or breastfeeding.
- Lack of effective contraception in childbearing age.
- Patients with brain, cerebral meninges or heart metastases.
- Severe or significant concomitant disease in the investigator's assessment.
- Urinary tract obstruction or/and hydronephrosis.
- Concurrent anticancer treatment.
- Myelosuppressive or nuclear treatment within 4 weeks before enrollment to the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.