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NCT06738680Not yet recruiting

PRedictive Value of Multiparametric Dynamic WB 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1

PRedictive Value of Multiparametric Dynamic Whole-body 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1 Study

Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Lung cancer is the leading cause of cancer deaths worldwide. Revolution of chemo-immunotherapy (CT-IO) in first-line of metastatic non-small-cell lung cancers (NSCLC) without actionable genomic alterations (AGAs) has dramatically improved prognosis, providing long response to a subset of patients. Because of a highly heterogeneous disease, majority of patients do not show long term benefit. Long axial field of view positron emission tomography (LAFOV-PET) scanner is a new emerging system allowing dynamic whole-body imaging with higher sensitivity, representing unique opportunity for oncological applications. The aim of this study is to determine if LAFOV-PET imaging biomarkers could early predict response to CT-IO in NSCLC.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
15 Nov 2024
Start date
30 Jan 2025
Primary completion date
30 Jan 2026
Lead sponsor
University Hospital, Brest
Diseases
Lung cancer
NCT number
NCT06738680

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 30 Jan 2025 to the primary completion date, 30 Jan 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ineligible for first-line chemo-immunotherapy

Lab values

  • Oncogenic addiction targetable in 1st line: EGFR, ALK, ROS1, RET

Age

  • Minor patients \<18 years

Other

  • Pregnancy or breast-feeding
  • Other histology than NSCLC
  • PET-FDG Scan contraindications
  • Refusal to participate

Who the study is looking for

  • Adult patients ≥ 18 years
  • With advanced, non-operable, non-radiatable or metastatic NSCLC
  • Treatment-naïve patients
  • Eligible for first-line chemo-immunotherapy (anti-PD-1)
  • Written Non-objection
  • Eligible for LAFOV FDG-PET less than 21 days before initiation of treatment

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brest University Hospital
Coordinator of this site? Confirm its status
BrestFranceUnknown status
Morlaix Hospital Center
Coordinator of this site? Confirm its status
MorlaixFranceUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.