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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01773 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This is a single center, pilot, cross-sectional imaging study investigating the use of gallium-68 citrate PET in participants with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519).
The study population will consist of participants with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition.
Primary Objective:
I. To determine the association between maximum average of standard uptake value (SUVmax-ave) of target metastatic lesions on gallium-68 citrate PET with MYC amplification determined from analysis of circulating tumor DNA.
Secondary Objectives:
I. To determine the accuracy rate, sensitivity, specificity of gallium citrate PET in the detection of metastatic lesions as compared to standard staging scans including cross-sectional imaging of the abdomen/pelvis and whole body bone scan.
II. To determine the optimal dose of gallium-68 citrate and timing of scan post-injection to maximize tumor-to-background signal.
III. To characterize the safety profile of gallium-68 citrate.
Outline:
The study will involve gallium-68 PET scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of gallium scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment that will be completed within 12 weeks of baseline gallium citrate PET.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gallium-68 citrate, PET | Experimental | Participants will receive a single scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment received outside this study that will be completed within 12 weeks of baseline scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gallium-68 citrate | Drug | Given via IV at time of imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean maximum Standardized Uptake Value (SUVmax) | The mean and standard deviation of SUVmax of gallium-68 citrate (across all metastatic lesions per participant) will be reported. | Day of imaging (1 day) |
| Mean maximum Standardized Uptake Value (SUVmax-ave) | The mean and standard deviation of SUVmax-ave of gallium-68 citrate across all participants in the study cohort will be descriptively reported. | Day of imaging (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between SUVmax and MYC gene expression | For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and MYC gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation. |
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Inclusion Criteria:
For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET:
Exclusion Criteria:
For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET:
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| Name | Affiliation | Role |
|---|---|---|
| Rahul Aggarwal, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2022 | Jun 15, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C103850 | gallium citrate |
| C000615430 | Gallium-68 |
| D019343 | Citric Acid |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Positron Emission Tomography (PET) | Procedure | Imaging procedure |
|
|
| Day of imaging (1 day) |
| Correlation between SUVmax and transferrin receptor gene expression | For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and transferrin receptor gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation. | Day of imaging (1 day) |
| Mean SUVmax-ave percent change from baseline | For participants who undergo optional follow up gallium-68 citrate PET scan, the mean percent change from baseline in SUVmax-ave will be descriptively reported. | Up to 12 weeks |
| Sensitivity of gallium-68 PET | Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the sensitivity value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan. | Day of imaging (1 day) |
| Specificity of gallium-68 PET | Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the specificity of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan. | Day of imaging (1 day) |
| Positive predictive value (PPV) of gallium-68 PET | Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the positive predictive value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan. | Day of imaging (1 day) |
| Number of participants with reported treatment-emergent adverse events | The frequency and severity of adverse events following gallium-68 citrate injection will be descriptively reported, using CTCAE version 4.03. | Up to 12 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |