Набор скоро начнётся NCT07624994

Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine

Фаза II С лечением Digital Osteoarthritis or Rheumatoid Arthritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg.
Кому может быть актуально: Состояния в реестре: Digital Osteoarthritis or Rheumatoid Arthritis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Functional Imaging of Digital Osteoarthritis and Rheumatoid Arthritis Using 99mTc-NTP 15-5 in Nuclear Medicine: Phase II Clinical Study

Обзор

This study is a phase Ii clinical trial aimed to evaluate the performance of 99mTc-NTP 15-5 to identify a pathological hand joint in each group ; digital osteoarthrosis and rheumatoid arthritis

Вмешательства

Препарат 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)

Первичные конечные точки

to evaluate the performance of 99mTc-NTP 15-5 to identify a pathological hand joint in each group: digital osteoarthritis (DOA) and rheumatoid arthritis (RA) [Срок оценки: 2 hour after injection]

Вторичные конечные точки (7)

to evaluate the diagnostic performance of 99mTc-NTP 15-5 for differential diagnosis between DAO and RA. [Срок оценки: 2 hours after injection of 99mTc-NTP 15-5]
to evaluate the performance of 99mTc-NTP imaging 15-5 by joint group in each pathology. [Срок оценки: 2 hours after injection]
to determine the prevalence of joint damage by pathology according to the scintigraphic method and the radioclinical method [Срок оценки: 2 hours after injection]
To quantitatively analyze the fixation of 99mTc-NTP 15-5 on the hand joints, in each pathology. [Срок оценки: 2 hours after injection]
to evaluate the inter-observer reproducibility of visual and quantitative readings [Срок оценки: 2 hours after injection]
to describe the fixation of 99mTc-NTP 15-5 on skeletal joints other than hand joints, based on visual analysis. [Срок оценки: 2 hours after injection]
to evaluate the tolerance of 99mTc-NTP 15-5. [Срок оценки: during 1 week after injection of 99mTc-NTP 15-5]

Критерии участия

Критерии включения

Karnofsky index > 70%
Obtaining written, signed and dated informed consent
Affiliation to a health insurance plan
For women of childbearing age (fertile, after menarche and until postmenopausal unless sterile after surgery) including on GnRH agonist for ovarian suppression: serum pregnancy test negative at baseline (within 7 days before injection of 99mTc-NTP 15-5). Menopause is defined as amenorrhea for at least 12 consecutive months with no other cause and FSH and oestradiol levels consistent with those of the post-menopausal period.
Ability and willingness to respect study visits, exams as well as protocol.

RA Group:

certain diagnosis of rheumatoid arthritis less than 5 years old, according to the ACR/EULAR criteria,
symptomatic (finger pain > 4 /10 on a numerical scale),
active synovitis (clinical and ultrasound),

Group DOA:

certain diagnosis of symptomatic DOA less than 5 years old (finger pain > 4 /10 on a numerical scale),
stopping NSAIDs for at least 8 days before the injection,

Критерии исключения

Ongoing use of non-steroidal anti-inflammatory drugs,
Treatment by local joint corticoid infiltration at the hand level in the month preceding the administration of 99mTc-NTP 15-5,
History of osteoarticular hand surgery.
History of hand soft tissue surgery in the past 6 months
Patients or patients 18 years old,
Pregnant or breastfeeding patient,
IMC>30,
History of known allergy to excipients contained in the 99mTc-NTP 15-5 solution,
Persons deprived of their liberty, under guardianship/curatorship, or safeguarding of justice,
Inability to submit to the medical follow-up of the trial for geographical, family, social or psychological reasons. These conditions must be discussed with the patient before registration in the study.

RA Group: