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Активно (без набиране) Фаза 2 NCT04561492

Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Multiple Myeloma

Спонсор: Nantes University Hospital

Налично на: БГ
Обобщение
The aim of our study is to confirm the relevance of PET using \[68Ga\]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga -PentixaFor/FDG discordances explored.
Кой може да участва
Inclusion Criteria: * Age ≥ 18 years * Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment * Written and signed informed consent (obtained on the screening day at the latest and before any investigation) * ECOG (Eastern Cooperative Oncology Group) \< 2 * Patient affiliated to or beneficiary of the National Health Service Exclusion Criteria: * HIV positive, active Hepatitis B or C * Childbearing or child breast feeding women * Women or men without effective contraceptive barrier if needed * eGFR \< 50 ml/min by MDRD or CKDEPI * Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Known active infection * Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus * Patient under guardianship or trusteeship * Patient under judicial protection
Интервенции
[68Ga]Ga-PentixaFor
DRUG
Места на провеждане 3
Франция (3)
CHU Bordeaux
Bordeaux
Nantes UH
Nantes
APHP - Site Tenon
Paris
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.09.2021
Крайна дата
21.05.2030
Регистрационен номер
NCT04561492
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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