N/A
N=109
PET Enhanced CT Scan Performance in Cancer
Cancer Disease Progression
Bottom Line
View on ClinicalTrials.gov: NCT01881620 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions — 0.7254; 0.7854; 0.7597; 0.6711 Weighted kappa concordance coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- COMBI TEP : PET / enhanced CT scan (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Bergonié
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions |
0.7254; 0.7854; 0.7597; 0.6711; 1 | — |
| SECONDARY Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level |
0.6528 | — |
| SECONDARY Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions |
0.8526; 0.8153; 0.7452; 0.8722; 1 | — |
| SECONDARY Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level |
0.7859 | — |
| SECONDARY Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions |
0.8141; 0.7991; 0.7947; -0.0095; 1 | — |
| SECONDARY Intra-observer Reproducibility of Injected CT Scanat a Patient Level |
0.7984 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
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.
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01881620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.