CClinicalTrials.gg
CompletedNCT03403127Updated Aug 14, 2020

PET CT Re-Planning NSCLC (4DCT-PET)

An interventional study of PET/CT Scans in Lung Cancer and Non-Small Cell Lung Cancer, sponsored by University Health Network, Toronto. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-14.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.

02

Conditions studied

  • Lung Cancer
  • Non-Small Cell Lung Cancer
03

Who can participate

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

Inclusion criteria

  • Age equal to or more than 18 years old
  • Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
  • Chemo-RT patients of any stage of NSCLC
  • Patients with a measurable tumor on CT scan.
  • Patients who are able to lie supine for two consecutive 25 minutes sessions.

Exclusion criteria

Exclusion Criteria:

  • Trimodality patients who will have surgery within 2 months post RT
  • Previous radiotherapy to intended treatment volumes.
  • Patients with recurrent disease
  • Active malignancy other than lung cancer
  • Pregnancy
  • Failure to provide written informed consent
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Interventions

  • Diagnostic testPET/CT Scans

    PET Imaging requires the use of an investigational drug, a radioactively-labelled sugar called 18F-Fluorodeoxyglucose (FDG). FDG is glucose labelled with a radioactive fluorine atom. It is given by intravenous injection and is particularly absorbed by cancer cells. The radioactive signal given off by the FDG can then be detected by the PET scanner providing an image of the cancer (or tumour).

05

What researchers measure

Primary outcomes

  1. GTV volumes

    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC.

    Time frame: 2 weeks post RT treatment

  2. GTV volumes

    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC

    Time frame: 4 weeks post RT Treatment

  3. GTV volumes

    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC

    Time frame: 7 weeks post RT Treatment

  4. GTV volumes

    he ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC

    Time frame: 3 months post RT treatment

  5. GTV volumes

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    Time frame: 2 weeks post RT Treatment

  6. GTV Volumes

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    Time frame: 4 weeks post RT Treatment

  7. GTV Volumes

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    Time frame: 7 weeks post RT Treatment

  8. GTV volumes

    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    Time frame: 3 months post RT treatment

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03403127
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
May 20, 2008
Primary completion
Mar 25, 2013
Completion
Apr 28, 2020
Last update
Aug 14, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion