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CompletedNCT00199615Updated Jul 30, 2025

Follow-up of Patients With Curative-intent Surgical Resection for NSCLC

An interventional study of PET in Non-small Cell Lung Cancer, sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer (NSCLC).No international consensus is published concerning follow-up of resected NSCLC patients.Recent studies have outlined that positron emission tomography (PET) scanning may be accurate in early detection of recurrences by comparison to computed tomography (CT). The aim of this study is to compare follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients. PET and CT are interpreted separately by two nuclear physicians and two radiologists. The direct cost of follow-up procedure is determined in the two groups. The calculated sample is composed of 60 patients in each arm to detect significant difference. The Ethics Committee of Universitary Hospital of Limoges approves the study.

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Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • lung cancer, 18 FDG, PET
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 73 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients who underwent resection for NSCLC
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients with a mixed histology profile that included small cell carcinoma or neuroendocrine tumor cells.
  • Patients with non-resected NSCLC or with metastasis
  • Patients who have previous malignancy, except basal cell carcinoma of the skin -
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
73 participants (actual)

Interventions

  • ProcedurePET

    Intravenous injection of glucose labeled Fluor 18.Le patient remains fasted at least 6 hours before the start of the examination. The review lasted 1 hour, during which the patient should not move.

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What researchers measure

Primary outcomes

  1. Disease-free survival from the date of operation to the date of recurrence or censured at the date of last follow-up visit or date of the death.

Secondary outcomes

  1. - Overall survival from the date of the operation to the death

  2. - Specificity, sensibility and accuracy of TEP to detect recurrence

  3. - Direct cost of follow-up from the Frenc Healthcare insurance

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Study locations

1 site
  • Pathologie Respiratoire
    Limoges, 87042, France
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References and documents

Publications

  • Monteil J, Vergnenegre A, Bertin F, Dalmay F, Gaillard S, Bonnaud F, Melloni B. Randomized follow-up study of resected NSCLC patients: conventional versus 18F-DG coincidence imaging. Anticancer Res. 2010 Sep;30(9):3811-6. PubMed 20944175 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00199615
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Apr 2001
Completion
Dec 2006
Last update
Jul 30, 2025

Study contacts

Boris MELLONI, MD
principal investigator · University Hospital, Limoges

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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