TumorsPhase 1NCT02441972
Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
A Phase 1 study testing 18F-Al-NOTA-PRGD2 PET/CT in people with Tumors and Carcinoma, Bronchogenic, run by Wuxi No. 4 People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumors, Carcinoma, Bronchogenic, Breast Carcinoma
- What is being tested?
- 18F-Al-NOTA-PRGD2 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2020
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers or patients with age more than 18 yeas;
- The patients have been diagnosed with cancer or suspected with cancer;
- It must fulfill the ethical requirements and subjects have signed an informed consent.
Who cannot join
- Pregnancy or nursing mothers;
- Having drugs or alcohol dependence;
- Hypersensitive to the active or inactive ingredients of the study drug;
- Having attended other drug clinical trials within three months;
- Cardiac functional insufficiency;
- Hepatic and renal function insufficiency;
- Hypertensive patients with serious complications;
- Endangering the safety of life.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuxi No. 4 People's Hospital
Wuxi, Jiangsu, 214000
Chunjing Yu, M.D., 15312238622, ycj_wxd1978@163.com
About this study
Official title: Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.
Read the detailed description
Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.
- Conditions
- Tumors, Carcinoma, Bronchogenic, Breast Carcinoma, Cancer of Head and Neck, Lymphoma, Malignant, Soft Tissue Neoplasms
- Being tested
- 18F-Al-NOTA-PRGD2 PET/CT
- Medical subject headings
- Neoplasms, Carcinoma, Bronchogenic, Breast Neoplasms, Head and Neck Neoplasms, Lymphoma, Soft Tissue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Al-NOTA-PRGD2 PET/CTDrug
Also called 18F-Alfatide II PET/CT
18F-Al-NOTA-PRGD2(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Al-NOTA-PRGD2 PET/CT | Experimental | Imaging with 18F-Al-NOTA-PRGD2 PET/CT. Receives: Drug: 18F-Al-NOTA-PRGD2 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)
Safety data were collected before and after injection of 18F-Al-NOTA-PRGD2. physical examination; ECG; laboratory parameters (blood routine, liver function and kidney function) and adverse events.
Measured: 1 day
Secondary outcomes (2)
radioactive distribution of normal organ, standard uptake value of tumor
Visual analysis whole body 18F-Al-NOTA-PRGD2 PET;Regions of interest (ROIs) were drawn manually on each image with the assistance of corresponding CT images. The results were expressed as standardized uptake value (SUV).
Measured: 60 minutes
Diagnostic performance analysis to assess "sensitivity,specificity,accuracy,etc"
compare the Diagnostic outcome to pathology or clinic follow-up,then to gather statistics of sensitivity,specificity,accuracy,etc.
Measured: 1 day-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TumorsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi No. 4 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weixing Wan, Professor, Study chair, Wuxi No. 4 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441972
- Sponsor's protocol ID
- LS2011051
- Status last verified
- Dec 2016
- First submitted
- 21 Apr 2015
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Beer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Clin Cancer Res. 2006 Jul 1;12(13):3942-9. doi: 10.1158/1078-0432.CCR-06-0266.
PubMed 16818691Beer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RGD and 18F-FDG. J Nucl Med. 2008 Jan;49(1):22-9. doi: 10.2967/jnumed.107.045864. Epub 2007 Dec 12.
PubMed 18077538Wang L, Zhu X, Xue Y, Huang Z, Zou W, Zhang Z, Yu M, Pan D, Wang K. Ultrasensitive detection of uveal melanoma using [18F]AlF-NOTA-PRGD2 PET imaging. EJNMMI Res. 2024 Jul 5;14(1):62. doi: 10.1186/s13550-024-01123-4.
PubMed 38967722
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
- ClinicalTrials.gov ID
- NCT02441972
- Acronym / sponsor ID
- LS2011051
- Conditions
- Tumors, Carcinoma, Bronchogenic, Breast Carcinoma, Cancer of Head and Neck, Lymphoma, Malignant, Soft Tissue Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wuxi No. 4 People's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 May 2015 (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 purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.
Detailed description
Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Al-NOTA-PRGD2 PET/CT | Experimental | Drug: 18F-Al-NOTA-PRGD2 PET/CTImaging with 18F-Al-NOTA-PRGD2 PET/CT. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers or patients with age more than 18 yeas;
- The patients have been diagnosed with cancer or suspected with cancer;
- It must fulfill the ethical requirements and subjects have signed an informed consent.
Key exclusion criteria (8 listed)
- Pregnancy or nursing mothers;
- Having drugs or alcohol dependence;
- Hypersensitive to the active or inactive ingredients of the study drug;
- Having attended other drug clinical trials within three months;
- Cardiac functional insufficiency;
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 |
|---|---|---|
| 18F-Al-NOTA-PRGD2 PET/CTAlso: 18F-Alfatide II PET/CT18F-Al-NOTA-PRGD2(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min. | Drug | 18F-Al-NOTA-PRGD2 PET/CT |
Primary outcome
Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)
Time frame: 1 day
Safety data were collected before and after injection of 18F-Al-NOTA-PRGD2. physical examination; ECG; laboratory parameters (blood routine, liver function and kidney function) and adverse events.
2 secondary outcomes
radioactive distribution of normal organ, standard uptake value of tumor
Time frame: 60 minutes
Diagnostic performance analysis to assess "sensitivity,specificity,accuracy,etc"
Time frame: 1 day-1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Results publication: PubMed 16818691Beer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Clin Cancer Res. 2006 Jul 1;12(13):3942-9. doi: 10.1158/1078-0432.CCR-06-0266.
- Results publication: PubMed 18077538Beer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RGD and 18F-FDG. J Nucl Med. 2008 Jan;49(1):22-9. doi: 10.2967/jnumed.107.045864. Epub 2007 Dec 12.
- Derived from this study: PubMed 38967722Wang L, Zhu X, Xue Y, Huang Z, Zou W, Zhang Z, Yu M, Pan D, Wang K. Ultrasensitive detection of uveal melanoma using [18F]AlF-NOTA-PRGD2 PET imaging. EJNMMI Res. 2024 Jul 5;14(1):62. doi: 10.1186/s13550-024-01123-4.
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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.
Weixing Wan, Professor study chair
Wuxi No. 4 People's Hospital
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 18F-Al-NOTA-PRGD2 PET/CT in people with Tumors and Carcinoma, Bronchogenic, run by Wuxi No. 4 People's Hospital at 1 site in China.
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 3 inclusion and 8 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 10 Mar 2017. 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 China. 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 Chunjing Yu, Dr. (86-15312238622, ycj_wxd1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite) (time frame: 1 day). 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 NCT02441972, which also lists 3 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 10 Mar 2017.