Kidney CancerNCT06148220
A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors
A study testing [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging in people with Kidney Cancer and Lymphomas, run by Huashan Hospital at 1 site in China.
Trial summary
The aim of this study was to establish and optimize the [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Cancer, Lymphomas, Positron Emission Tomography
- What is being tested?
- [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Sep 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18 and 65 years of age and of either sex.
- Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.
- Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Severe hepatic and renal insufficiency;
- Targeted therapy prior to radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
- Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- History of serious surgery in the last month.
- Those who have participated in other clinical trials during the same period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Yihui Guan, MD, 13764308300 ext. +86, guanyihui@hotmail.com
About this study
The aim of this study was to establish and optimize the [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.
- Conditions
- Kidney Cancer, Lymphomas, Positron Emission Tomography
- Being tested
- [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging
- Medical subject headings
- Kidney Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imagingRadiation
Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose
| Study group | Role | What they receive |
|---|---|---|
| patients with renal cancer | Experimental | Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose Receives: Radiation: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging |
| patients with lymphoma | Experimental | Intravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose Receives: Radiation: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete PET imaging
- Establishment and optimization of imaging method for [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 PET/CT imaging. 2. Evaluating the sensitivity and specificity of using [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 PET/CT in diagnosing renal cell carcinoma (especially metastatic clear cell renal carcinoma) and lymphoma.
Measured: 90mins from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Oct 2023
- Primary completion13 Jun 2024 (estimated)
- Study completion1 Sep 2024 (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 Kidney CancerStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148220
- Sponsor's protocol ID
- KY2023-779
- Status last verified
- Feb 2024
- First submitted
- 19 Nov 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou X, Wu Q, Zhai W, Zhang Y, Wu Y, Cao M, Wang C, Guan Y, Liu J, Xie F, Wei W. CD70-Targeted Immuno-PET/CT Imaging of Clear Cell Renal Cell Carcinoma: A Translational Study. J Nucl Med. 2024 Dec 3;65(12):1891-1898. doi: 10.2967/jnumed.124.268509.
PubMed 39510586
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors
- ClinicalTrials.gov ID
- NCT06148220
- Acronym / sponsor ID
- KY2023-779
- Conditions
- Kidney Cancer, Lymphomas, Positron Emission Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 28 Nov 2023 (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 aim of this study was to establish and optimize the [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with renal cancer | Experimental | Radiation: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imagingIntravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose |
| patients with lymphoma | Experimental | Radiation: [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imagingIntravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be between 18 and 65 years of age and of either sex.
- Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.
- Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
Key exclusion criteria (6 listed)
- Subjects meeting any of the following criteria will be excluded from 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 |
|---|---|---|
| [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imagingIntravenous injection of 3.7 MBq [0.1 mCi]/kg of [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 in a single dose | Radiation | patients with lymphoma, patients with renal cancer |
Primary outcome
Complete PET imaging
Time frame: 90mins from time of injection
1. Establishment and optimization of imaging method for [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 PET/CT imaging. 2. Evaluating the sensitivity and specificity of using [18F]RCCB6 or [68Ga]Ga-NOTA-RCCB6 PET/CT in diagnosing renal cell carcinoma (especially metastatic clear cell renal carcinoma) and lymphoma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 39510586Zhou X, Wu Q, Zhai W, Zhang Y, Wu Y, Cao M, Wang C, Guan Y, Liu J, Xie F, Wei W. CD70-Targeted Immuno-PET/CT Imaging of Clear Cell Renal Cell Carcinoma: A Translational Study. J Nucl Med. 2024 Dec 3;65(12):1891-1898. doi: 10.2967/jnumed.124.268509.
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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.
Fang Xie principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT imaging in people with Kidney Cancer and Lymphomas, run by Huashan 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 4 inclusion and 6 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 16 Feb 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 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.
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 Yihui Guan, MD (13764308300 ext. +86, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete PET imaging (time frame: 90mins from time of injection). 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 NCT06148220, 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 16 Feb 2024.