Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

bone scintigraphy

Haiquan Chen, Ph.D

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1006. In this prospective one-arm observational study, bone scintigraphy will be performed in T1N0M0 NSCLC patients with GGO lesion and other low risk factors of bone metastasis. The occurrence rate of bone metastasis in these patients will be analyzed to evaluate the necessity of bone scintigraphy in cT1N0M0 NSCLC patients.

Skeletal is a common metastatic site in patients with non-small cell lung cancer. The incidence of bone metastases is about 20-30％ in NSCLC patients. According to the NCCN guidelines, early lung cancer patients should also undergo bone scan or PETCT before surgery to determine the presence of bone metastases. However, all of the above methods use radionuclide reagents as tracers, which pose health hazards to patients and their contacts, including medical personnel. A retrospective study conducted by our center showed that only 0.95% of patients with cT1N0M0 non-small cell lung cancer had preoperative bone metastases. In patients with early stage lung cancer whose lesions are pure ground glass nodules, the probability of developing bone metastases is zero. The low risk factors for bone metastases from this retrospective study included preoperative examination of patients with CEA \<5 ng/ul and no bone-related symptoms. In patients with primary NSCLC who underwent CEA \<5 ng/ul preoperatively, no bone metastases occurred; in patients with negative bone-related symptoms, the incidence of bone metastases was only 0.18%. In the case of such patients, if the bone scan is performed, not only the potential damage to the patient is increased, but also the waste of medical resources and the burden on the patient from the perspective of health economics.

Therefore, our center is expected to conduct this prospective one-arm observational clinical trial. According to the low-risk factors derived from retrospective studies, bone scintigraphy was performed in patients with GGO lesion and other low risk factors of bone metastasis, and the incidence of bone metastasis was obtained. The necessity of bone scintigraphy in cT1N0M0 NSCLC patients would be evaluated.

This trial is recognizes in our institute as "Eastern Cooperative Thoracic Oncology Project (ECTOP-1006)"

Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer? (ECTOP-1006)

Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer?

The Number of cT1N0M0 NSCLC patients that had bone metastasis in this cohort

Fudan University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Prognostic interest of bone scintigraphy in bone metastatic prostate carcinoma (BMPC) has been shown. Recent technological advances allow to perform quantitative bone SPECT-CT in routine practice. The aim of this study is to assess the prognostic interest of quantitative bone SPECT-CT in BMPC.

Prostate adenocarcinoma is one of the most common cancer in men, and bone its most frequent distant metastasis location. 5-year survival has greatly increased these last two decades, with wide differences between countries. Nevertheless, the prognosis of castrate-resistant bone metastatic prostate cancer (BMPC) remains poor.

PCWG (Prostate Cancer Working Group) 2 has proposed in 2007 criteria to evaluate response to treatment for prostate cancer. There are based on composite data, including clinical signs (such as general condition and bone pain), Prostatic Specific Antigen (PSA) variation, CT scan (RECIST criteria) and bone scan. The scintigraphic part is based on whole body planar acquisition, and on the assessment of new uptakes. These bone scan criteria are simplistic, because only a visual analysis is possible, without consideration of changes in intensity. Moreover, these criteria consider the bone scan as a planar imaging, and it has been shown that Single Photon Emission Computed Tomography (SPECT) improved sensitivity, specificity, positive and negative predictive values in oncologic context. Finally, "PCWG2 (Prostate Cancer Working Group 2) recognizes that there are no validated criteria for response on radionuclide bone scan".

To reflect bone metastasis burden, a quantitative analysis method for bone scintigraphy, the Bone Scan Index (BSI), had been tested. BSI is based on the uptake of whole body planar imaging. While baseline BSI seemed to offer a poor correlation with overall survival (OS), on-treatment changes in BSI appeared to be a decent response marker. But a volumetric quantitative biomarker may improve the accuracy of this assessment.

The recent development of a new SPECT quantification tool (xSPECT Quant® tool, Siemens) could offer good performances on therapeutic assessment. The objective of this study is to assess the interest of this new quantitative volumetric method in bone scan response evaluation of BMPC.

Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma

Assessment of prognostic quantitative SPECT-CT parameters

Assessment of correlation between baseline PSA and baseline quantitative SPECT-CT parameters (SUVmax (max Standardized Uptake Value) of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism) (Spearman coefficient)

Assessment of correlation between survival (Progression Free Survival, Overall Survival, Disease Specific Survival) and baseline quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism)

Assessment of correlation between variations of PSA and variations of quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism) (Spearman coefficient)

Assessment of correlation between survival (Progression Free Survival, Overall Survival, Disease Specific Survival) and variations of quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism)

University Hospital, Brest

Neoplastic Processes

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Technetium Tc 99m Medronate

Radiopharmaceuticals

Injection of radioactive element (Tc-99m MDP) then imaging with gamma camera and low dose CT (SPECT/CT)

Tc-99m MDP and gamma camera

Maram M Shafeek, Resident

Samir S Mohamed, Professor

HebatAllah A Askar, Lecturer

Rehab M Helmy, Lecturer

The study aims to compare the diagnostic performance of planar bone scan and two bed SPECT/CT in detection of bone metastases in patients with urogenital cancer.

Genitourinary malignancies represent a heterogeneous group of diseases linked by anatomical and physiological function. Renal cell carcinoma (RCC); urothelial carcinoma of the bladder, ureter, and renal pelvis, and prostate adenocarcinoma (PC) are the most commonly encountered histological subtypes within this group. Planar bone scintigraphy (PBS) with di-phosphonate compounds is widely used, cost-effective and sensitive imaging modality for detecting osseous metastases especially in prostate cancer. However, it suffers from low specificity as well as low sensitivity in purely osteolytic lesions. Single-photon emission computed tomography (SPECT) is a three-dimensional acquisition method that has demonstrated greater sensitivity and specificity compared to planar images, especially for detecting vertebral metastases. The introduction of SPECT/CT images improves the lesion-to-background ratio, allows anatomic lesion localization, removes the superimposition of anatomical structures, such as urinary bladder activity, and provides anatomical data, thereby increasing the sensitivity, specificity and positive predictive value of bone scan. As the technology advances, current SPECT/CT machines have become capable of sequentially covering, and accurately merging, more than one field of view (FOV) in a reasonable time. In this study, we aim to compare the diagnostic performance of two-bed SPECT/CT images and planar bone scintigraphy in detection of bone metastases in genitourinary malignancies.

Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies

Analysis and comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans for the detection of osseous metastases in genitourinary malignancies.

Assiut University

Principal investigator

Infections

Musculoskeletal Diseases

Rare Diseases

Communicable Diseases

Osteosarcoma

Joint Diseases

Bone Diseases

Bone Neoplasms

Disease Attributes

Anti-Infective Agents

Fluorides

Listerine

Sodium Fluoride

Protective Agents

Anti-Infective Agents, Local

Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.

Intravenous injection of 4 MBq/kg for pediatric patients, or 5 MBq/kg for adult patients (maximum of 555 MBq), followed by a 45 minutes waiting time. Patients is then placed in supine position in a PET/CT scanner for a duration of no more than 30 minutes.

18F-sodium fluoride

Stéphanie Dubreuil

Éric Turcotte, MD

Eric E Turcotte, MD

Stephanie Dubreuil

Éric E Turcotte, MD

18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy. However, lack of universal tracer availability and higher costs contributed to the failure of 18F-NaF to systematically supplant bone scintigraphy as a standard of care.

Recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. Since 18F-NaF is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage.

The study aims to evaluate the safety profile of 18F-NaF injection. Moreover, a patient registry will be compiled in order to perform sub-studies on 18F-NaF diagnostic performance on diverse bone and articular diseases.

Every patient in need and/or eligible for a standard 99mTc-biphosphonate bone scintigraphy is eligible to participate to this study. Patient data and examination results will be compiled and monitored. The safety profile of 18F-NaF produced in the primary site will be determined.

18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment

Open-label Clinical Trial on the Safety and Efficacy of 18F-sodium Fluoride (NaF) PET Imaging in Patients in Need of a Standard 99mTc Bone Scintigraphy

A registry monitoring eventual adverse effects for this radiopharmaceutical agent will be compiled. Usual procedures will be applied to divulgate any serious adverse effects.

Using the patient registry, and in the eventual sub-studies to come, the diagnostic performance of 18F-NaF-PET will be compared to similar available imaging tests, most notably 99mTc-biphosphonate bone scintigraphy.

Pathology data from the diverse conditions eligible for the 18F-NaF PET scan will be also monitored when available. Prognostic value from the imaging data will be compared with those obtained from the pathology.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer? (ECTOP-1006)	NCT03689439	Bone Metastases	bone scintigrap...	18 Years - 80 Years	Fudan University
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma	NCT03382522	Prostate Cancer		18 Years -	University Hospital, Brest
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma	NCT03382522	Prostate Cancer		18 Years -	University Hospital, Brest
Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer? (ECTOP-1006)	NCT03689439	Bone Metastases	bone scintigrap...	18 Years - 80 Years	Fudan University
Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies	NCT05597215	Bone Metastases Urogenital Canc...	Tc-99m MDP and ...	18 Years -	Assiut University
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma	NCT03382522	Prostate Cancer		18 Years -	University Hospital, Brest
18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment	NCT04842071	Bone Cancer Articular Disea... Infectious Dise...	18F-sodium fluo...	-	Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Spots Global Cancer Trial Database for bone scintigraphy