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NCT Number: NCT03689439

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Chest Hospital, Hefei, Anhui, China

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About this study

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)"

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of bone related diseases.
  • History of other kinds of cancer

Treatment and study plan

bone scintigraphy

Diagnostic Test

bone scintigraphy

Primary outcomes

  1. The Occurrence Rate of Bone metastasis in cT1N0M0 NSCLC patients

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 28, 2018
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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