Pathological AngiogenesisPhase 1NCT02666547
68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis
A Phase 1 study testing 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT and 18F-FET PET/CT in people with Pathological Angiogenesis, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Angiogenesis
- What is being tested?
- 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT and 18F-FET PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age ≤ 85 years old
- Karnofsky index: ≥ 80%
- Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and for which a 18F-FDG (or a 18F-FETfor glioma) is indicated : (1) glioma (WHO I, II-IV), (2) malignant melanoma, (3) cancer of upper respiratory tract, (4) breast cancer,(5) bone metastasis, (6) ovarian cancer, (7) lung cancer,(8) non-Hodgkinian malignant lymphoma with extra- lymphatic nodes extension, (9) neuroendocrine tumors, (10) pancreatic cancer,(11) oesophagus cancer,(12) stomach cancer. 10 patients will be included per type of cancer.
- Informed consent signed
Who cannot join
- Incapacity to sign the informed consent
- Pregnancy, breastfeeding
- Age <18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois, Nuclear Medicine
Lausanne, Canton of Vaud, 1011
About this study
Official title: Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis
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.
Read the detailed description
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:
- On the images of PET/CT: SUVmax, SUVmoyen, VOI ( mL ), SUV41 % ratio [mean SUV of pixels ≥ 41 % of the SUVmax] of lesions / SUV
- On the images of CT: size of the lesions measured in 3D (axial, coronal and sagittal), density in Hounsfield unit (HU)
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
- Conditions
- Pathological Angiogenesis
- Being tested
- 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, 18F-FET PET/CT
- Keywords
- 68Ga-NODAGA-RGD, 18F-FDG, 18F-FET, PET/CT, neoangiogenesis
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-RGD PET/CTDrug
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
18F-FDG PET/CTRadiation
3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
18F-FET PET/CTRadiation
200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs | Other | 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 Receives: Drug: 68Ga-NODAGA-RGD PET/CT; Radiation: 18F-FDG PET/CT; Radiation: 18F-FET PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 10 days
Secondary outcomes (2)
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.
Measured: 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)
Measured: within 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMar 2014
- Primary completionAug 2023
- Study completionSep 2023
Why it stopped: lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pathological AngiogenesisStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- George Coukos, MD PhD, Head of oncology
- Responsible party
- Principal investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- John O Prior, MD, PhD, Principal investigator, Lausanne University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666547
- Sponsor's protocol ID
- 220/12
- Status last verified
- Jun 2024
- First submitted
- 24 Jan 2016
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Durante S, Dunet V, Gorostidi F, Mitsakis P, Schaefer N, Delage J, Prior JO. Head and neck tumors angiogenesis imaging with 68Ga-NODAGA-RGD in comparison to 18F-FDG PET/CT: a pilot study. EJNMMI Res. 2020 May 7;10(1):47. doi: 10.1186/s13550-020-00638-w.
PubMed 32382869Dietz M, Dunet V, Mantziari S, Pomoni A, Dias Correia R, Testart Dardel N, Boughdad S, Nicod Lalonde M, Treglia G, Schafer M, Schaefer N, Prior JO. Comparison of integrin alphavbeta3 expression with 68Ga-NODAGA-RGD PET/CT and glucose metabolism with 18F-FDG PET/CT in esophageal or gastroesophageal junction cancers. Eur J Hybrid Imaging. 2023 Feb 1;7(1):3. doi: 10.1186/s41824-023-00162-9.
PubMed 36720731
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis
- ClinicalTrials.gov ID
- NCT02666547
- Acronym / sponsor ID
- 220/12
- Conditions
- Pathological Angiogenesis
- Keywords
- 68Ga-NODAGA-RGD, 18F-FDG, 18F-FET, PET/CT, neoangiogenesis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of resources
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- George Coukos, MD PhD, Head of oncology
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- On the images of PET/CT: SUVmax, SUVmoyen, VOI ( mL ), SUV41 % ratio [mean SUV of pixels ≥ 41 % of the SUVmax] of lesions / SUV
- On the images of CT: size of the lesions measured in 3D (axial, coronal and sagittal), density in Hounsfield unit (HU)
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs | Other | Drug: 68Ga-NODAGA-RGD PET/CT, Radiation: 18F-FDG PET/CT, Radiation: 18F-FET PET/CTActive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≤ 85 years old
- Karnofsky index: ≥ 80%
- Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and for which a 18F-FDG (or a 18F-FETfor glioma) is indicated : (1) glioma (WHO I, II-IV), (2) malignant melanoma, (3) cancer of upper respiratory tract, (4) breast cancer,(5) bone metastasis, (6) ovarian cancer, (7) lung cancer,(8) non-Hodgkinian malignant lymphoma with extra- lymphatic nodes extension, (9) neuroendocrine tumors, (10) pancreatic cancer,(11) oesophagus cancer,(12) stomach cancer. 10 patients will be included per type of cancer.
- Informed consent signed
Key exclusion criteria (3 listed)
- Incapacity to sign the informed consent
- Pregnancy, breastfeeding
- Age <18 years
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 |
|---|---|---|
| 68Ga-NODAGA-RGD PET/CT200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull | Drug | 68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs |
| 18F-FDG PET/CT3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body | Radiation | 68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs |
| 18F-FET PET/CT200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull | Radiation | 68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs |
Primary outcome
Comparison of each method of imaging for detection of tumors
Time frame: within 10 days
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
2 secondary outcomes
ROC analysis and comparison of areas under the curve
Time frame: Within 10 days
Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments
Time frame: within 10 days
Results and safety
The study was stopped early (reason given: lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Results publication: PubMed 32382869Durante S, Dunet V, Gorostidi F, Mitsakis P, Schaefer N, Delage J, Prior JO. Head and neck tumors angiogenesis imaging with 68Ga-NODAGA-RGD in comparison to 18F-FDG PET/CT: a pilot study. EJNMMI Res. 2020 May 7;10(1):47. doi: 10.1186/s13550-020-00638-w.
- Derived from this study: PubMed 36720731Dietz M, Dunet V, Mantziari S, Pomoni A, Dias Correia R, Testart Dardel N, Boughdad S, Nicod Lalonde M, Treglia G, Schafer M, Schaefer N, Prior JO. Comparison of integrin alphavbeta3 expression with 68Ga-NODAGA-RGD PET/CT and glucose metabolism with 18F-FDG PET/CT in esophageal or gastroesophageal junction cancers. Eur J Hybrid Imaging. 2023 Feb 1;7(1):3. doi: 10.1186/s41824-023-00162-9.
- Individual participant dataSharing planned: No
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.
John O Prior, MD, PhD principal investigator
Lausanne University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT and 18F-FET PET/CT in people with Pathological Angiogenesis, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of resources). Results are not available in the source record.
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?
Comparison of each method of imaging for detection of tumors (time frame: within 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666547, which also lists 2 linked publications.
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 20 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.