Clinical trial NCT03689439: Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer? (ECTOP-1006)
Official title: Is Bone Scintigraphy Necessary in cT1N0M0 GGO Non-Small Cell Lung Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Metastases
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cT1N0M0 NSCLC Patients

Brief summary: 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.

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)"

Eligibility criteria: 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

Primary outcomes:
measure: The Occurrence Rate of Bone metastasis in cT1N0M0 NSCLC patients
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Chest Hospital
state: An Hui
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: He Nan
city: Yangzhou
country: China
facility: Jiang Du People's Hospital
state: Jiang Su
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
city: Changchun
country: China
facility: Jilin Cancer Hospital
Study officials:
affiliation: Shanghai Cancer Center
name: Haiquan Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.