NL-OMON51764
Withdrawn
Phase 2
A prospective, international, multi-centre, open-label,single-arm phase II study investigating the predictive value of [68Ga]Ga-PentixaFor PET imaging in primary and isolated secondary CNS lymphoma patients - Diagnostic imaging in CNS lymphoma patients.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Central Nervous system lymphoma
- Sponsor
- PentixaPharm GmbH
- Enrollment
- 6
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All study patients must meet all the following criteria:
- •1\.Written informed consent obtained according to international guidelines and
- •local laws by patient (or legally acceptable representative if the patient is
- •temporarily legally not competent owing to his/her disease). \[Note: No invasive
- •study\-specific procedures may be carried out until this consent has been given.]
- •2\.Patient aged 18 years or above (either sex).
- •3\.Histologically confirmed primary or secondary CNSL based on cytology/flow
- •cytometry of cerebrospinal fluid (CSF) or brain biopsy.
- •4\.Disease exclusively located in the CNS (primary CNSL or secondary CNSL with
- •isolated CNS relapse). Subjects who had undergone allogeneic stem cell
Exclusion Criteria
- •Any patient meeting one or more of the following criteria will not be included:
- •1\.Known hypersensitivity to \[68Ga]Ga\-PentixaFor or its components.
- •2\.Contraindication for contrast\-enhanced MRI as set out in the relevant
- •institutional guidelines (e.g., pacemaker, defibrillator, aneurysm clip, metal
- •in the body, renal insufficiency, severe claustrophobia etc.).
- •3\.Contraindication for the use of gadolinium contrast for MRI.
- •4\.Contraindication for PET according to institutional guidelines (weight\-based,
- •e.g. weight \> 180 kg).
- •5\.Inability to lie still for the entire imaging time.
- •6\.Systemic lymphoma manifestation (outside the CNS).
Outcomes
Primary Outcomes
Not specified
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