Colorectal CancerEarly Phase 1NCT03385148
The Clinical Application of 68Ga Labeled ssDNA Aptamer Sgc8 in Healthy Volunteers and Colorectal Patients
A Early Phase 1 study testing 68Ga-Sgc8 in people with Colorectal Cancer, run by Xijing Hospital at 2 sites in China.
Trial summary
The protein tyrosine kinase-7 (PTK7) is overexpressed in various types of human cancers. As a specific imaging agent of PTK7, 68Ga-Sgc8 was investigated in this study to assess its safety, biodistribution and dosimetric properties in healthy volunteers, and to preliminarily evaluate its application in colorectal… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 68Ga-Sgc8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2017to 30 Dec 2019
- Phase
- Early 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to provide a written informed consent
- Males and females, ≥18 years old；
- Newly diagnosed colorectal patients and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available.
Who cannot join
- Females planning to bear a child recently or with childbearing potential；
- Known severe allergy or hypersensitivity to IV radiographic contrast；
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Xijing Hospital Nuclear Medicine Department
Xi'an, Shaanxi, 710032
Jing Wang, Doctor, 86-29-84775449, wangjing@fmmu.edu.cn
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Zhe Wang, Dr., 862984771048, dadaxueshan@163.com
About this study
Official title: Diagnostic Performance and Evaluation Efficacy of a Novel PTK7 PET Radiotracer 68Ga-SGC8
The protein tyrosine kinase-7 (PTK7) is overexpressed in various types of human cancers. As a specific imaging agent of PTK7, 68Ga-Sgc8 was investigated in this study to assess its safety, biodistribution and dosimetric properties in healthy volunteers, and to preliminarily evaluate its application in colorectal patients.
Read the detailed description
The protein tyrosine kinase-7 (PTK7), also known as colon carcinoma kinase-4 (CCK4), is a member of the receptor tyrosine kinase superfamily, which is evolutionarily conserved and contains seven immunoglobulin domains, a transmembrane domain, and a catalytically inactive kinase domain. PTK7 controls tissue morphogenesis and patterning by affecting cell polarity, migration as well as tissue regeneration and wound healing. It's reported that PTK7 plays an important role in the motility and invasivity of cancer cells and is overexpresses in many different types of human cancers, including colon, lung, gastric, breast cancer etc, making it a potentially attractive target for quantitative imaging and therapy.
Sgc8, a 41 oligonucleotides single-stranded DNA aptamer, which was selected by cell based systematic evolution of ligands by exponential enrichment (SELEX), has been identified as a specific ligand of PTK7. In this study, Sgc8 was linked to a bi-functional group NOTA for 68Ga chelation. The previous studies showed that the Sgc8 derivatives have a high accumulation in PTK7 positive tumors, suggesting the feasibility of 68Ga-Sgc8 for clinical translation for cancer detection.
Colorectal cancer (CRC) represents the third common type of cancer and the fourth leading cause of death in the worldwide, and has one of the highest rates of synchronous or metachronous malignancy among all cancers. According to the Colon Cancer NCCN Guidelines (version 3.2014), 50-60% CRC patients are with metastases, and 80-90% of these metastatic patients may have unresectable liver metastasis. Therefore, early detection of the lesions is of utmost importance with respect to administration of early treatment and improved survival. It's reported that PTK7 is overexpressed in CRC, and the expression was correlated with tumor differentiation, lymph node metastasis, distant metastasis and TNM stage of CRC patients, suggesting that PTK7 may be a desirable target to predict the occurrence and prognosis of colorectal tumor.
In this study, investigators will first measur the dosimetry of 68Ga-Sgc8 in healthy volunteers, and then evaluate the tracer in colorectal patients, to assess its diagnostic value.
- Conditions
- Colorectal Cancer
- Being tested
- 68Ga-Sgc8
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-Sgc8Drug
Also called PET/CT
underwent a standard routine 18F-FDG PET/CT first, and then injected 10~20 MBq 68Ga-Sgc8
| Study group | Role | What they receive |
|---|---|---|
| colorectal patients | Experimental | the colorectal patients undergo 68Ga-Sgc8 PET/CT Receives: Drug: 68Ga-Sgc8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis effecacy
Assess advantage or concordance of 68Ga-Sgc8 PET results with 18F-FDG PET imaging
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start1 Jan 2017
- Primary completion15 Dec 2017
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Wang, Dr., Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385148
- Sponsor's protocol ID
- KY20162077-2
- Status last verified
- Jan 2017
- First submitted
- 19 Dec 2017
- Last updated
- 28 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Evaluation Efficacy of a Novel PTK7 PET Radiotracer 68Ga-SGC8
- ClinicalTrials.gov ID
- NCT03385148
- Acronym / sponsor ID
- KY20162077-2
- Conditions
- Colorectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 28 Dec 2017 (actual)
- 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 protein tyrosine kinase-7 (PTK7) is overexpressed in various types of human cancers. As a specific imaging agent of PTK7, 68Ga-Sgc8 was investigated in this study to assess its safety, biodistribution and dosimetric properties in healthy volunteers, and to preliminarily evaluate its application in colorectal patients.
Detailed description
The protein tyrosine kinase-7 (PTK7), also known as colon carcinoma kinase-4 (CCK4), is a member of the receptor tyrosine kinase superfamily, which is evolutionarily conserved and contains seven immunoglobulin domains, a transmembrane domain, and a catalytically inactive kinase domain. PTK7 controls tissue morphogenesis and patterning by affecting cell polarity, migration as well as tissue regeneration and wound healing. It's reported that PTK7 plays an important role in the motility and invasivity of cancer cells and is overexpresses in many different types of human cancers, including colon, lung, gastric, breast cancer etc, making it a potentially attractive target for quantitative imaging and therapy.
Sgc8, a 41 oligonucleotides single-stranded DNA aptamer, which was selected by cell based systematic evolution of ligands by exponential enrichment (SELEX), has been identified as a specific ligand of PTK7. In this study, Sgc8 was linked to a bi-functional group NOTA for 68Ga chelation. The previous studies showed that the Sgc8 derivatives have a high accumulation in PTK7 positive tumors, suggesting the feasibility of 68Ga-Sgc8 for clinical translation for cancer detection.
Colorectal cancer (CRC) represents the third common type of cancer and the fourth leading cause of death in the worldwide, and has one of the highest rates of synchronous or metachronous malignancy among all cancers. According to the Colon Cancer NCCN Guidelines (version 3.2014), 50-60% CRC patients are with metastases, and 80-90% of these metastatic patients may have unresectable liver metastasis. Therefore, early detection of the lesions is of utmost importance with respect to administration of early treatment and improved survival. It's reported that PTK7 is overexpressed in CRC, and the expression was correlated with tumor differentiation, lymph node metastasis, distant metastasis and TNM stage of CRC patients, suggesting that PTK7 may be a desirable target to predict the occurrence and prognosis of colorectal tumor.
In this study, investigators will first measur the dosimetry of 68Ga-Sgc8 in healthy volunteers, and then evaluate the tracer in colorectal patients, to assess its diagnostic value.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal patients | Experimental | Drug: 68Ga-Sgc8the colorectal patients undergo 68Ga-Sgc8 PET/CT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be able to provide a written informed consent
- Males and females, ≥18 years old；
- Newly diagnosed colorectal patients and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available.
Key exclusion criteria (5 listed)
- Females planning to bear a child recently or with childbearing potential；
- Known severe allergy or hypersensitivity to IV radiographic contrast；
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
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-Sgc8Also: PET/CTunderwent a standard routine 18F-FDG PET/CT first, and then injected 10~20 MBq 68Ga-Sgc8 | Drug | colorectal patients |
Primary outcome
diagnosis effecacy
Time frame: 2 years
Assess advantage or concordance of 68Ga-Sgc8 PET results with 18F-FDG PET imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- 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.
Jing Wang, Dr. study chair
Xijing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-Sgc8 in people with Colorectal Cancer, run by Xijing Hospital at 2 sites 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 5 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Zhe Wang, Dr. (862984771048, dadaxueshan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis effecacy (time frame: 2 years). 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 28 Dec 2017.