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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Metastases
• Intervention / Treatment: Diagnostic test: bone scintigraphy

Detailed Description

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)"

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

• Study Contact: Name: HANG LI, M.D; Phone Number: 13611607904; Email: drlihang@163.com

Study Locations

• China
  • Changchun, China
    • Jilin Cancer Hospital
  • An Hui
    • Hefei, An Hui, China, 230000
      • Anhui Chest Hospital
  • He Nan
    • Zhengzhou, He Nan, China, 450000
      • Henan Cancer Hospital
  • Jiang Su
    • Yangzhou, Jiang Su, China, 225200
      • Jiang Du People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

cT1N0M0 NSCLC Patients

Description

Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Age 18-80 years old;
3. ECOG score ≤ 2 points;
4. CT shows that the main lesion is considered to be ground glass nodular lung cancer;
5. Preoperative examination CEA <5ng/ul
6. There are no bone related symptoms
7. There is no obvious absolute surgical contraindication for preoperative examination.

Exclusion Criteria:

1. History of bone related diseases.
2. History of other kinds of cancer

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Occurrence Rate of Bone metastasis in cT1N0M0 NSCLC patients	The Number of cT1N0M0 NSCLC patients that had bone metastasis in this cohort	1 month

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Haiquan Chen, Ph.D, Shanghai Cancer Center

Publications and helpful links

General Publications

• Li H, Ye T, Li N, Xia G, Li B, Zhang Y, Hu H, Sun Y, Zhang Y, Xiang J, Ma D, Weng Y, Liu S, Jia C, Qian B, Gu Y, Li Y, Song S, Chen H. Is 99m Tc bone scintigraphy necessary in the preoperative workup for patients with cT1N0 subsolid lung cancer? A prospective multicenter cohort study. Thorac Cancer. 2021 Feb;12(4):415-419. doi: 10.1111/1759-7714.13752. Epub 2020 Nov 19.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ECTOP-1006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No