Clear Cell Renal Cell CarcinomaPhase 2NCT05879510
68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
A Phase 2 study testing 68Ga-NY104 PET/CT in people with Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- 68Ga-NY104 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Jul 2025
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 y
- Presence of a renal mass
- Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Written informed consent provided for participation in the trial
- In the opinion of investigator, willing and able to comply with required study procedures.
Who cannot join
- On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
- Intercurrent medical condition that renders the patient ineligible for surgery.
- Pregnancy or breastfeeding.
- Severe claustrophobia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wenjia Zhu, MD, zhuwenjia_pumc@163.com
About this study
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.
Read the detailed description
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. Both imaging modalities will be performed prior to resection of the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will be interpreted by one reader, all of whom will provide independent and blinded interpretations. Imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. The exploration into the detection of metastases by 68Ga-NY104 PET/CT in comparison to diagnostic CT will also be performed.
The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.
63 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- 68Ga-NY104 PET/CT
- Keywords
- 68Ga-NY104, PET/CT, renal mass
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NY104 PET/CTDiagnostic test
Also called 68Ga-NYM005 PET/CT
Participants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator.
The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NY104 PET/CT | Experimental | Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Receives: Diagnostic Test: 68Ga-NY104 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary reading of renal lesions identified on 68Ga-NY104 PET/CT
Define lesion as PET positive or PET negative lesion. The kidney lesion is designated as positive if the SUVmax of kidney lesions is higher than that of liver (reference).
Measured: From study completion to 1 month after completion
Histological classification of operated renal lesions
The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.
Measured: From study completion to 1 month after completion
Secondary outcomes (13)
SUVmax of renal lesions identified on 68Ga-NY104 PET/CT
For kidney lesions, the tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax. The ROI should be drawn with caution not to include any adjacent normal kidney parenchyma.
Measured: From study completion to 1 month after completion
SUVmax of liver uptake on 68Ga-NY104 PET/CT
The liver uptake (SUVmax (liver)) is used as the references to define PET positive lesions. It is measured by placing a 3-cm region of interest in right lobe at the level of porta hepatis. Focal lesion should be avoided if present.
Measured: From study completion to 1 month after completion
Tumor grade of operated renal lesions
The tumor grade of operated renal lesions will be determined according to Fuhrmann grading system
Measured: From study completion to 1 month after completion
Intensity of CAIX staining of operated renal lesions
The intensity of CAIX staining of operated renal lesions will be based on a 4-point scale from 0-3 according to the method of Bui et al, 2003
Measured: From study completion to 1 month after completion
Extent of CAIX staining of operated renal lesions
The extent of CAIX staining of operated renal lesions will be determined by the percentage of the target tissue sample that have positive CAIX expression according to the method of Bui et al, 2003
Measured: From study completion to 1 month after completion
Binary reading of renal lesions identified on diagnostic CT
A tumor will be described as clear cell renal carcinoma on a triphasic CT if one of the following two parameters is applicable:
- Significant (>85 HU) enhancement in the cortico-medullary phase
- Significant (>45 HU) enhancement in the parenchyma / excretory phase
Measured: From study completion to 1 month after completion
Size of renal lesions identified on diagnostic CT
The longest diameter of the tumor will be measured on diagnostic CT
Measured: From study completion to 1 month after completion
Number of metastatic lesions identified on 68Ga-NY104 PET/CT
For metastasis evaluation, any focal accumulation of 68Ga-NY104 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NY104 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.
Measured: From study completion to 1 month after completion
Location of metastatic lesions identified on 68Ga-NY104 PET/CT
For metastasis evaluation, any focal accumulation of 68Ga-NY104 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NY104 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.
Measured: From study completion to 1 month after completion
Szie of metastatic lesions identified on 68Ga-NY104 PET/CT
For metastasis evaluation, any focal accumulation of 68Ga-NY104 outside the kidneys that cannot be explained by physiologic uptake is interpreted as focal lesion. The SUVmax and tumor-to-background should be evaluated. Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue. Any focal lesion identified on 68Ga-NY104 PET will be considered to be positive for metastasis if SUVmax (lesion) is no less than SUVmax (liver) or tumor-to-background ratio is higher than 1.
Measured: From study completion to 1 month after completion
Number of metastatic lesions on diagnostic CT
The number of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.
Measured: From study completion to 1 month after completion
Location of metastatic lesions on diagnostic CT
The number of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.
Measured: From study completion to 1 month after completion
Size of metastatic lesions on diagnostic CT
The number of metastatic lesions on diagnostic CT will be determined by radiologist according to the typical location, enhancement pattern of the lesions.
Measured: From study completion to 1 month after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, MD, Principal investigator, Peking Uion Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879510
- Sponsor's protocol ID
- NYCRPS
- Status last verified
- Jul 2023
- First submitted
- 18 May 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
- ClinicalTrials.gov ID
- NCT05879510
- Acronym / sponsor ID
- NYCRPS
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- 68Ga-NY104, PET/CT, renal mass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 30 May 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.
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.
Detailed description
This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. Both imaging modalities will be performed prior to resection of the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will be interpreted by one reader, all of whom will provide independent and blinded interpretations. Imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. The exploration into the detection of metastases by 68Ga-NY104 PET/CT in comparison to diagnostic CT will also be performed.
The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.
63 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NY104 PET/CT | Experimental | Diagnostic Test: 68Ga-NY104 PET/CTEach patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 y
- Presence of a renal mass
- Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
- Expected survival of at least 3 months
- ECOG ≤ 2
Key exclusion criteria (4 listed)
- On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
- Intercurrent medical condition that renders the patient ineligible for surgery.
- Pregnancy or breastfeeding.
- Severe 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 |
|---|---|---|
| 68Ga-NY104 PET/CTAlso: 68Ga-NYM005 PET/CTParticipants will be administered a single, intravenous bolus of 68Ga-NY104 The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NY104 administration. | Diagnostic test | 68Ga-NY104 PET/CT |
Primary outcome
Binary reading of renal lesions identified on 68Ga-NY104 PET/CT
Time frame: From study completion to 1 month after completion
Define lesion as PET positive or PET negative lesion. The kidney lesion is designated as positive if the SUVmax of kidney lesions is higher than that of liver (reference).
Histological classification of operated renal lesions
Time frame: From study completion to 1 month after completion
The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.
13 secondary outcomes
SUVmax of renal lesions identified on 68Ga-NY104 PET/CT
Time frame: From study completion to 1 month after completion
SUVmax of liver uptake on 68Ga-NY104 PET/CT
Time frame: From study completion to 1 month after completion
Tumor grade of operated renal lesions
Time frame: From study completion to 1 month after completion
Intensity of CAIX staining of operated renal lesions
Time frame: From study completion to 1 month after completion
Extent of CAIX staining of operated renal lesions
Time frame: From study completion to 1 month after completion
Binary reading of renal lesions identified on diagnostic CT
Time frame: From study completion to 1 month after completion
Size of renal lesions identified on diagnostic CT
Time frame: From study completion to 1 month after completion
Number of metastatic lesions identified on 68Ga-NY104 PET/CT
Time frame: From study completion to 1 month after completion
Location of metastatic lesions identified on 68Ga-NY104 PET/CT
Time frame: From study completion to 1 month after completion
Szie of metastatic lesions identified on 68Ga-NY104 PET/CT
Time frame: From study completion to 1 month after completion
Number of metastatic lesions on diagnostic CT
Time frame: From study completion to 1 month after completion
Location of metastatic lesions on diagnostic CT
Time frame: From study completion to 1 month after completion
Size of metastatic lesions on diagnostic CT
Time frame: From study completion to 1 month after completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: Yes. Available upon request
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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.
Li Huo, MD principal investigator
Peking Uion Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-NY104 PET/CT in people with Clear Cell Renal Cell Carcinoma, run by Peking Union Medical College 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 7 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 13 Jul 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Li Huo, MD (18612672038, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary reading of renal lesions identified on 68Ga-NY104 PET/CT (time frame: From study completion to 1 month after completion). The study lists 2 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 13 Jul 2023.