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Cancer Disease ProgressionCOMBITEPNCT01881620

PET Enhanced CT Scan Performance in Cancer

A study testing COMBI TEP : PET / enhanced CT scan in people with Cancer Disease Progression, run by Institut Bergonié.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypothesis: The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Disease Progression
What is being tested?
COMBI TEP : PET / enhanced CT scan
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
No sites listed yet
Study dates
19 Mar 2010to 15 Jul 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient with a cancerous disease for which PET scan is indicated in the SOR (Standards - Options - Recommendations) FDG PET 2003 updated in 2006 must be included in the trial, in the following locations:
  • Digestive cancers
  • Colorectal cancer
  • Preoperative evaluation in local and metastatic recurrence
  • Location of recurrences, in case of ACE increase in a previously operated patient.
  • Esophageal cancer: initial staging.
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  • Pancreatic cancer
  • Initial staging,
  • Differential diagnosis with chronic pancreatitis.
  • Liver cancer: differential diagnosis of liver metastases, cholangiocarcinoma and benign tumors in the case of an isolated hepatic localization.
  • Digestive Endocrine tumors: staging in case of normal pentetreotide scintigraphy.
  • Lung cancer
  • Initial staging,
  • Diagnosis of lung isolated lesion > 1 cm.
  • Head and neck cancer
  • Initial pretreatment staging,
  • Recurrence diagnosis
  • Lymphoma
  • Initial staging of Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL) and aggressive follicular lymphomas,
  • Diagnosis of minimal residual disease of HD and aggressive NHL,
  • Early assessment of treatment response.
  • Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
  • Ovarian cancer recurrence
  • Age ≥ 18 years.
  • Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
  • Woman of childbearing age with negative pregnancy test and / or contraception.
  • Patient with informed consent signed.
  • Patient affiliated to social security schemes.

Who cannot join

  • Iodine known allergy.
  • Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
  • Known renal failure (creatinine clearance <60ml/min).
  • Indications against Xenetix ®:
  • Hypersensitivity to Xenetix ® or any of the excipients,
  • History of an immediate response or delayed cutaneous reaction to Xenetix ® injection.
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  • Thyrotoxicosis.
  • Pregnant or lactating women.
  • Unable to undergo medical follow up for geographical, social or psychological reasons,
  • Private of freedom patient and adult under a legal guardianship or unable to consent.

About this study

Official title: PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study

Hypothesis:

The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility.

This study is a prospective single center study.

Read the detailed description

Hypothesis:

We would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility. This study allows us to assess the feasibility of such a large-scale study, but also to evaluate COMBI TEP performance. From these estimates, we can then consider a comparative study to evaluate the performance of COMBI PET.

This study is a prospective single center study.

Being tested
COMBI TEP : PET / enhanced CT scan
Keywords
PET scan, CT scan, Diagnostic performance
Medical subject headings
Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMBI TEP : PET / enhanced CT scanDevice

    Also called diagnostic imaging exam

    diagnostic imaging exam

Study groups in NCT01881620
Study groupRoleWhat they receive
COMBI TEP : PET / enhanced CT scanExperimentalCOMBI TEP : PET / enhanced CT scan
Receives: Device: COMBI TEP : PET / enhanced CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions

    The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study

    Measured: 1 year

Secondary outcomes (5)
  1. Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level

    The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study

    Measured: 1 year

  2. Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions

    For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study

    Measured: 1 year

  3. Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level

    The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.]. Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study

    Measured: 1 year

  4. Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions

    For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.

    Measured: 1 year

  5. Intra-observer Reproducibility of Injected CT Scanat a Patient Level

    The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2013 (estimated)
  2. Study start19 Mar 2010
  3. Primary completion19 Jul 2012
  4. Study completion15 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01881620
Sponsor's protocol ID
IB2009-70
Acronym
COMBITEP
Status last verified
Jul 2019
First submitted
5 Nov 2012
Last updated
18 Nov 2024
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing COMBI TEP : PET / enhanced CT scan in people with Cancer Disease Progression, run by Institut Bergonié.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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