Neuroendocrine CarcinomaPhase 1NCT02970786
Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
A Phase 1 study testing Injection of 68Ga-NODAGA-E(c[RGDyK])2 in people with Neuroendocrine Carcinoma and Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Neuroendocrine Carcinoma, Breast Cancer, Ovarian Cancer
- What is being tested?
- Injection of 68Ga-NODAGA-E(c[RGDyK])2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Jun 2017
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
- Capable of understanding and giving full informed consent
Who cannot join
- Pregnancy
- Lactation
- Obesity (weight above 140 kg)
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, 2100
About this study
The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.
This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
Read the detailed description
The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.
This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E[c(RGDyK)]2. In addition, the quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).
- Conditions
- Neuroendocrine Carcinoma, Breast Cancer, Ovarian Cancer
- Being tested
- Injection of 68Ga-NODAGA-E(c[RGDyK])2
- Medical subject headings
- Carcinoma, Neuroendocrine, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 68Ga-NODAGA-E(c[RGDyK])2Drug
Following one injection of 68Ga-NODAGA-E(c[RGDyK])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NODAGA-E(c[RGDyK])2 PET | Experimental | One injection of 68Ga-NODAGA-E(c[RGDyK])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection Receives: Drug: Injection of 68Ga-NODAGA-E(c[RGDyK])2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution
Change in biodistribution estimated by PET
Measured: 2 hours
Dosimetry
Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c[RGDyK])2.
Measured: 2 hours
Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.
Measured: 48 hours
Secondary outcomes (1)
Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue
The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Martini Clausen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970786
- Sponsor's protocol ID
- AK-2015-1
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
- ClinicalTrials.gov ID
- NCT02970786
- Acronym / sponsor ID
- AK-2015-1
- Conditions
- Neuroendocrine Carcinoma, Breast Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 22 Nov 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.
The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.
This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
Detailed description
The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.
This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E[c(RGDyK)]2. In addition, the quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).
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-E(c[RGDyK])2 PET | Experimental | Drug: Injection of 68Ga-NODAGA-E(c[RGDyK])2One injection of 68Ga-NODAGA-E(c[RGDyK])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
- Capable of understanding and giving full informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Lactation
- Obesity (weight above 140 kg)
- Claustrophobia
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 |
|---|---|---|
| Injection of 68Ga-NODAGA-E(c[RGDyK])2Following one injection of 68Ga-NODAGA-E(c[RGDyK])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection | Drug | 68Ga-NODAGA-E(c[RGDyK])2 PET |
Primary outcome
Biodistribution
Time frame: 2 hours
Change in biodistribution estimated by PET
Dosimetry
Time frame: 2 hours
Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c[RGDyK])2.
Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.
Time frame: 48 hours
1 secondary outcome
Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Individual participant dataSharing planned: No
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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.
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 Injection of 68Ga-NODAGA-E(c[RGDyK])2 in people with Neuroendocrine Carcinoma and Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Nov 2016. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malene M Clausen, MD, PhD (+4522524536, malene.martini.clausen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution (time frame: 2 hours). The study lists 3 primary outcomes in all. 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 22 Nov 2016.