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.
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.
Show all 28Show fewer
- 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.
Show all 10Show fewer
- 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.
- Conditions
- Cancer Disease Progression
- 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 group | Role | What they receive |
|---|---|---|
| COMBI TEP : PET / enhanced CT scan | Experimental | COMBI 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.
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)
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
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
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
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
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.
- First posted19 Jun 2013 (estimated)
- Study start19 Mar 2010
- Primary completion19 Jul 2012
- Study completion15 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer Disease ProgressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAZEAU Anne Laure, MD, Study chair, Institut Bergonié
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET / Enhanced CT Scan Performance in Cancer (Positron Emission Tomography Combined With Computed Tomography or Vascular Contrast CT Scan). COMBI TEP Study
- ClinicalTrials.gov ID
- NCT01881620
- Acronym / sponsor ID
- COMBITEP / IB2009-70
- Conditions
- Cancer Disease Progression
- Keywords
- PET scan, CT scan, Diagnostic performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 19 Mar 2010 (actual)
- Primary completion
- 19 Jul 2012 (actual)
- Study completion
- 15 Jul 2015 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMBI TEP : PET / enhanced CT scan | Experimental | Device: COMBI TEP : PET / enhanced CT scanCOMBI TEP : PET / enhanced CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
- Lung cancer
- Head and neck cancer
- Lymphoma
Key exclusion criteria (10 listed)
- Iodine known allergy.
- Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
- Known renal failure (creatinine clearance <60ml/min).
- Indications against Xenetix ®:
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMBI TEP : PET / enhanced CT scanAlso: diagnostic imaging examdiagnostic imaging exam | Device | COMBI TEP : PET / enhanced CT scan |
Primary outcome
Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions
Time frame: 1 year
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
5 secondary outcomes
Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level
Time frame: 1 year
Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions
Time frame: 1 year
Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level
Time frame: 1 year
Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions
Time frame: 1 year
Intra-observer Reproducibility of Injected CT Scanat a Patient Level
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Site internet du promoteur, l'Institut BergoniéLink provided by the sponsor.
Related trials for Cancer Disease Progression
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
Not yet recruitingPhase 1/2
ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1
Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage III
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingObservational study
Dynamic ctDNA Monitoring in Advanced Malignant Phyllodes Tumors of the Breast
Malignant Phyllodes Tumor of the Breast
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAZEAU Anne Laure, MD study chair
Institut Bergonié
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.