Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447103
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-03
Brief Title:
An Investigational Scan 89Zr-DFO-GmAb PETCT Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX CAIX PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
89Zr-DFO-GmAb PETCT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography PETcomputed tomography CT compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back recurrent For some patients the risk of recurrence after surgery remains high Conventional CT methods such as contrast-enhanced CT may not detect small volume or micrometastatic disease PETCT with radiotracers such as 89Zr-DFO-GmAb may improve detection of tumor cells Girentuximab GmAb a monoclonal antibody is tagged with zirconium-89 a radioactive atom which is also known as an isotope The zirconium-89 89Zr isotope is attached to girentuximab with desferrioxamine DFO and this combined product is called 89Zr-DFO-girentuximab 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer in the case of this research 89Zr-DFO-GmAb Because some cancers including clear cell renal cell cancer take up 89Zr-DFO-GmAb it can be seen with PET CT utilizes x-rays that traverse body from the outside CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patients body Using contrast agents with CT scan to enhance the images contrast-enhanced CT is standard of care imaging 89Zr-DFO-GmAb PETCT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery
Detailed Description:
PRIMARY OBJECTIVE
I To compare the lesion detection rate ie positivity rate per patient of zirconium Zr 89 girentuximab 89Zr-DFO-GmAb PETCT compared to the standard of care diagnostic contrast-enhanced CT alone at 4-12 weeks from surgical resection based on blinded independent central review BICR
SECONDARY OBJECTIVES
I To establish safety of 89Zr-DFO-GmAb in patients with intermediate-high or high risk imaged in the post-nephrectomy or metastasectomy setting
II To compare the positive predictive value PPV of 89Zr-DFO-GmAb PETCT in patients with available lesion validation by 1 histopathology biopsyresection 2 evidence of growth under surveillance or 3 reduction of size under treatment and 4 unequivocal confirmation of malignancy on a different imaging modality
III To assess the recurrence-free survival of individuals withwithout evidence of disease based on 89Zr-DFO-GmAb PETCT staging results PETCT designated M1 versus vs M0
EXPLORATORY OBJECTIVES
I Correlate level of histological CAIX expression H Score from the primary tumor to 89Zr-TLX250 standardized uptake values SUVs in patients with visualized disease on 89Zr-DFO-GmAb PETCT
II To identify the standardized uptake value SUV cut-off for 89Zr-DFO-GmAb suitable for the detection of metastatic lesions in the postoperative setting
III To evaluate the performance of established prognostic transcriptomic classifiers from the nephrectomy specimen on disease-free survival
IV To evaluate if circulating tumor DNA ctDNA for the detection of molecular residual disease MRD correlates with the presence of active disease seen on 89Zr-DFO-GmAb PETCT or predicts disease-free survival
OUTLINE
Patients receive 89Zr-DFO-GmAb intravenously IV over 3 minutes on day 0 then undergo whole body PETCT and standard of care SOC diagnostic contrast-enhanced CT scan on day 7 Patients also blood sample collection on study In addition patients may undergo bone scan and CT or magnetic resonance imaging MRI of the brain on study as clinically indicated
After completion of study intervention patients are followed up at 8 16 and 24 months
I To compare the lesion detection rate ie positivity rate per patient of zirconium Zr 89 girentuximab 89Zr-DFO-GmAb PETCT compared to the standard of care diagnostic contrast-enhanced CT alone at 4-12 weeks from surgical resection based on blinded independent central review BICR
SECONDARY OBJECTIVES
I To establish safety of 89Zr-DFO-GmAb in patients with intermediate-high or high risk imaged in the post-nephrectomy or metastasectomy setting
II To compare the positive predictive value PPV of 89Zr-DFO-GmAb PETCT in patients with available lesion validation by 1 histopathology biopsyresection 2 evidence of growth under surveillance or 3 reduction of size under treatment and 4 unequivocal confirmation of malignancy on a different imaging modality
III To assess the recurrence-free survival of individuals withwithout evidence of disease based on 89Zr-DFO-GmAb PETCT staging results PETCT designated M1 versus vs M0
EXPLORATORY OBJECTIVES
I Correlate level of histological CAIX expression H Score from the primary tumor to 89Zr-TLX250 standardized uptake values SUVs in patients with visualized disease on 89Zr-DFO-GmAb PETCT
II To identify the standardized uptake value SUV cut-off for 89Zr-DFO-GmAb suitable for the detection of metastatic lesions in the postoperative setting
III To evaluate the performance of established prognostic transcriptomic classifiers from the nephrectomy specimen on disease-free survival
IV To evaluate if circulating tumor DNA ctDNA for the detection of molecular residual disease MRD correlates with the presence of active disease seen on 89Zr-DFO-GmAb PETCT or predicts disease-free survival
OUTLINE
Patients receive 89Zr-DFO-GmAb intravenously IV over 3 minutes on day 0 then undergo whole body PETCT and standard of care SOC diagnostic contrast-enhanced CT scan on day 7 Patients also blood sample collection on study In addition patients may undergo bone scan and CT or magnetic resonance imaging MRI of the brain on study as clinically indicated
After completion of study intervention patients are followed up at 8 16 and 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01928 | REGISTRY | CTRP Clinical Trial Reporting Program | None |