Идёт набор NCT04857502

99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

Ранняя фаза I С лечением Prostate Carcinoma Recurrent Prostate Carcinoma

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-based PSMA Imaging and Surgery Agent, Computed Tomography, Single Photon Emission Computed Tomography.
Кому может быть актуально: Состояния в реестре: Prostate Carcinoma, Recurrent Prostate Carcinoma. Базовые параметры: Без ограничений · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
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

99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation

Обзор

This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I\&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.

Подробное описание

PRIMARY OBJECTIVE:

I. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I\&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.

SECONDARY OBJECTIVES:

I. To correlate the 99mTc-PSMA-I\&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.

II. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I\&S administration.

OUTLINE:

The first 5 patients receive an initial dose of 99mTc-PSMA-I\&S intravenously (IV) followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\&S IV before surgery.

Вмешательства

Препарат 99mTc-based PSMA Imaging and Surgery Agent
Given via IV injection
Процедура Computed Tomography
Undergo SPECT/CT
Процедура Single Photon Emission Computed Tomography
Undergo SPECT/CT

Первичные конечные точки

The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax) [Срок оценки: time from injection to imaging (range: 1-46 hours)]

Вторичные конечные точки (2)

99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts/minute) and level of PSMA expression quantified by histopathology (IHC score) [Срок оценки: time from injection to imaging (range: 1-46 hours)]
The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function [Срок оценки: time from injection to imaging (range: 1-46 hours)]

Критерии участия

Критерии включения

Men with PCa (primary or recurrent disease)
Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
Men who are scheduled for pelvic LN dissection (PLND)
Men who can provide oral and written informed consent
Men who can comply with study procedures