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18F-FSPG PET/CT for Cancer Patients on Therapy

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
StatusTamamlandı
Sponsorlar
Andrei Iagaru
Əməkdaşlar
National Cancer Institute (NCI)

Açar sözlər

Mücərrəd

The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.

Təsvir

OUTLINE:

Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.

PRIMARY OBJECTIVE:

Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.

SECONDARY OBJECTIVES:

- Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.

- Safety and tolerability of 18F-FSPG and 18F-FDG.

Tarixlər

Son Doğrulandı: 11/30/2018
İlk təqdim: 10/31/2015
Təxmini qeydiyyat təqdim edildi: 11/03/2015
İlk Göndərmə: 11/05/2015
Son Yeniləmə Göndərildi: 12/10/2018
Son Yeniləmə Göndərildi: 01/02/2019
İlk təqdim edilmiş nəticələrin tarixi: 09/19/2018
İlk təqdim edilmiş QC nəticələrinin tarixi: 12/10/2018
İlk göndərilən nəticələrin tarixi: 01/02/2019
Həqiqi Təhsilin Başlama Tarixi: 06/30/2015
Təxmini İlkin Tamamlanma Tarixi: 12/13/2016
Təxmini İşin Tamamlanma Tarixi: 12/13/2016

Vəziyyət və ya xəstəlik

B-Cell Neoplasm
Estrogen Receptor Negative
HER2/Neu Negative
Metastatic Renal Cell Cancer
Progesterone Receptor Negative
Stage III Mesothelioma
Stage III Renal Cell Cancer
Stage IIIA Breast Cancer
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Stage IV Mesothelioma
Stage IV Non-Small Cell Lung Cancer
Stage IV Renal Cell Cancer
Triple-Negative Breast Carcinoma

Müdaxilə / müalicə

Drug: 18F-FSPG and 18F-FDG Intragroup Comparision

Drug: 18F-FSPG and 18F-FDG Intragroup Comparision

Faza

Faza 2

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: 18F-FSPG and 18F-FDG Intragroup Comparision
Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
Drug: 18F-FSPG and 18F-FDG Intragroup Comparision
Administered intravenously (IV)

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərAll
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

Inclusion Criteria:

- Written informed consent

- Able to complete a PET/CT scan without the use of sedation

- Females:

- Of childbearing potential must:

- Not be nursing

- Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT

- Not of childbearing potential must be:

- Physiologically postmenopausal (cessation of menses for more than 1 year)

- Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)

- Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent

- Scheduled to begin therapy

- The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)

- Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)

- No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week

Exclusion Criteria:

- Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration

- Known sensitivity to 18F FSPG or components of the preparation

- Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety

Nəticə

İlkin nəticə tədbirləri

1. Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment [Baseline and up to 2 years]

Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.

İkincili Nəticə Tədbirləri

1. Number of Treatment-Related Adverse Events [Baseline to up to 2 years]

Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.

2. Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs [Baseline and up to 2 years]

Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).

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