Prostate CancerPhase 1NCT02840617
ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
A Phase 1 study testing Indocyanine Green (ICG) in people with Prostate Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Indocyanine Green (ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed prostate cancer;
- Able to accept total prostatectomy;
- Patient has given its informed consent.
Who cannot join
- Allergic to ICG or iodine;
- High-grade hepatic insufficiency
- refuse attending the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
Guangzhou, Guangdong
Rongqin RQ Zheng, doctor, 0086-02085252010, zssyzrq@163.com
Hui-chao HC Zhou, doctor, 0086-02085252374, zhcgrace@163.com
About this study
Official title: A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system in helping prostate biopsy and lymph node dissection in the future.
Read the detailed description
The investigators will conduct an in vivo and in vitro pilot study in order to evaluate the diagnostic performance of fluorescence in the detection of prostate cancer and metastatic lymph nodes. All the patients included in this study will receive a radical prostatectomy after intravenous injection of 0.4 mg/Kg of ICG. ICG will be administered immediately after the patient is anesthetized. The fluorescence analysis will be performed intraoperatively by laparoscopic imaging and after surgery by hand-held imaging. The prostate or lymph nodes specimen with or without fluorescence signal will be sent to the Department of Pathology for pathological analysis. The histopathological procedure will be performed without knowledge of fluorescence analysis.
- Conditions
- Prostate Cancer
- Being tested
- Indocyanine Green (ICG)
- Keywords
- ICG, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG)Drug
Also called ICG
| Study group | Role | What they receive |
|---|---|---|
| ICG injection group | Experimental | ICG will be intravenously administered over a 10 second period immediately after the patient was anesthetized. The fluorescence will be performed during and after the surgery, respectively. Receives: Drug: Indocyanine Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect prostate cancer in vivo and in vitro compared to histological analysis
Measured: 1 week post-surgery
Secondary outcomes (1)
sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect metastatic lymph nodes in vivo and in vitro compared to histological analysis
Measured: 1 week post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongqin Zheng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Rongqin Zheng RQ Zheng, doctor, Study chair, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840617
- Sponsor's protocol ID
- sysu160511
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Greco F, Cadeddu JA, Gill IS, Kaouk JH, Remzi M, Thompson RH, van Leeuwen FW, van der Poel HG, Fornara P, Rassweiler J. Current perspectives in the use of molecular imaging to target surgical treatments for genitourinary cancers. Eur Urol. 2014 May;65(5):947-64. doi: 10.1016/j.eururo.2013.07.033. Epub 2013 Aug 7.
PubMed 23957947
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
- ClinicalTrials.gov ID
- NCT02840617
- Acronym / sponsor ID
- sysu160511
- Conditions
- Prostate Cancer
- Keywords
- ICG, prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 21 Jul 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 aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system in helping prostate biopsy and lymph node dissection in the future.
Detailed description
The investigators will conduct an in vivo and in vitro pilot study in order to evaluate the diagnostic performance of fluorescence in the detection of prostate cancer and metastatic lymph nodes. All the patients included in this study will receive a radical prostatectomy after intravenous injection of 0.4 mg/Kg of ICG. ICG will be administered immediately after the patient is anesthetized. The fluorescence analysis will be performed intraoperatively by laparoscopic imaging and after surgery by hand-held imaging. The prostate or lymph nodes specimen with or without fluorescence signal will be sent to the Department of Pathology for pathological analysis. The histopathological procedure will be performed without knowledge of fluorescence analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG injection group | Experimental | Drug: Indocyanine Green (ICG)ICG will be intravenously administered over a 10 second period immediately after the patient was anesthetized. The fluorescence will be performed during and after the surgery, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed prostate cancer;
- Able to accept total prostatectomy;
- Patient has given its informed consent.
Key exclusion criteria (3 listed)
- Allergic to ICG or iodine;
- High-grade hepatic insufficiency
- refuse attending the study
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 |
|---|---|---|
| Indocyanine Green (ICG)Also: ICG | Drug | ICG injection group |
Primary outcome
sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
Time frame: 1 week post-surgery
sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect prostate cancer in vivo and in vitro compared to histological analysis
1 secondary outcome
sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
Time frame: 1 week post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Background: PubMed 23957947Greco F, Cadeddu JA, Gill IS, Kaouk JH, Remzi M, Thompson RH, van Leeuwen FW, van der Poel HG, Fornara P, Rassweiler J. Current perspectives in the use of molecular imaging to target surgical treatments for genitourinary cancers. Eur Urol. 2014 May;65(5):947-64. doi: 10.1016/j.eururo.2013.07.033. Epub 2013 Aug 7.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Rongqin Zheng RQ Zheng, doctor study chair
Third Affiliated Hospital, Sun Yat-Sen University
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 Indocyanine Green (ICG) in people with Prostate Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University 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 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: status not confirmed, as of the sponsor's last update on 21 Jul 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 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 Rongqin Zheng RQ Zheng, doctor (0086-02085252010, zhengrq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer (time frame: 1 week post-surgery). 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 NCT02840617, which also lists 1 linked publication.
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 21 Jul 2016.