A Phase 1 interventional study of 68Ga-NODAGA-RGD PET/CT and 18F-FDG PET/CT in Pathological Angiogenesis, sponsored by University of Lausanne Hospitals. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by University of Lausanne Hospitals · Phase 1, Interventional, and Diagnostic
This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or 18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent tumor.
The purpose of this study is to assess the value of 68Ga-NODAGA-RGD PET/CT for detection of neoangiogenesis at level of neoplastic processes, in patients, compared to 18F-FDG PET/CT (tumors other than glioma) or 18F-FET PET/CT (patients affected by glioma) and to determine the respective diagnostic contribution of every technique.
Every patient will undergo a routine 18F-FDG (or 18F-FET) PET/CT followed by a 68Ga-NODAGA-RGD PET / CT specific for the study within the next 7 days.
(each image procedure duration: 2h)
The criteria of primary evaluation for each of the techniques will be defined:
The 18F-FDG/18F-FET and 68Ga-NODAGA-RGD PET / CTs will be analyzed at first separately then will be compared according to the methods described in the analysis
81 studies on the registry are indexed under Neovascularization, Pathologic; 7 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 55 interventional studies indexed under Neovascularization, Pathologic.
Browse Neovascularization, Pathologic studies →University of Lausanne Hospitals is the lead sponsor of 120 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Comparator: 68Ga-NODAGA-RGD radiotracer All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT or a 18F-FET PET/CT
Drug: 68Ga-NODAGA-RGD PET/CT · Radiation: 18F-FDG PET/CT · Radiation: 18F-FET PET/CT
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull
3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull
Comparison of each method of imaging for detection of tumors
To compare the capacity of each of the techniques and their combination to detect tumors, to determine the composition of these tumors (neoangiogenesis, metabolism, necrosis), their extension, the changes due to treatment
Time frame: within 10 days
ROC analysis and comparison of areas under the curve
A ROC analysis will be realized as well as a comparison of AUCs, to determine the superiority of a method compared to the other one, using a parametric test comparing of the AUC curves and ROC curves respectively by an established algorithm. The criteria of interpretation and positivity will be defined in a standard way on the images 18F-FDG / 18F-FET and 68Ga-NODAGA-RGD.
Time frame: Within 10 days
Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments
The sensibility for detection of tumor by the 68Ga-NODAGA-RGD will be assessed and compared with the standard routine extension assessements including 18F-FDG PET/CT or18F-FET PET/CT, CT or any other complementary exam (US, MRI)
Time frame: within 10 days
Plan to share: No
Ran from Mar 2014 to primary completion in Aug 2023, 113 months.
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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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