Renal Cell CarcinomaNCT01502228

PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma

A study testing 150-Water, 62Cu-ethylglyoxal bis and Positron Emission Tomography in people with Renal Cell Carcinoma, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of PET perfusion imaging in management of renal carcinoma… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Cell Carcinoma
What is being tested?: 150-Water, 62Cu-ethylglyoxal bis and Positron Emission Tomography
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Feb 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information.
Patients with a diagnosis of relapsed Stage IV renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the PET/CT field-of-view that can include the heart.
Being considered for systemic therapy with Sunitinib

Who cannot join

Women who are pregnant, breast-feeding, or of childbearing potential and not using birth control
Having no telephone or a reliable way in which study personal can contact them
Subjects who are claustrophobic and cannot tolerate imaging procedures
Subjects who weigh > 350 lb. (upper weight limit of scanner beds)

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Conditions: Renal Cell Carcinoma
Being tested: 150-Water, 62Cu-ethylglyoxal bis, Positron Emission Tomography, Sunitinib
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.

150-WaterDrug
Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
62Cu-ethylglyoxal bisDrug
Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV.
Positron Emission TomographyProcedure or surgery
Also called Seimens Biograph 64 TruePoint system
PET Scan
SunitinibDrug

Study groups in NCT01502228
Study group	Role	What they receive
62Cu-ETS PET assessment	Experimental	CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection Receives: Drug: 150-Water; Drug: 62Cu-ethylglyoxal bis; Procedure: Positron Emission Tomography; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
Measured: Baseline

Secondary outcomes (1)

Maximum Standard Uptake Value (SUV) for Lesion Data
Average values of the magnitude of tumor perfusion before and 14-28 days after initiation of Sunitinib treatment as measured by the maximum standard uptake value for all the lesion data. Standard uptake values were calculated as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity tracer. There were 14 patients who had a baseline reading and 12 patients who had a reading after treatment.
Measured: Baseline and 14-28 days after initiation of Sunitinib

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Feb 2014

First posted30 Dec 2011 (estimated)
Study startOct 2011
Primary completionFeb 2014
Study completionFeb 2014

Why it stopped: No further funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01502228
Sponsor's protocol ID: IUCRO-0279
Status last verified: Feb 2019
First submitted: 28 Dec 2011
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

All Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT01502228
Acronym / sponsor ID: IUCRO-0279
Conditions: Renal Cell Carcinoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: No further funding
Enrolment: 14 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: Oct 2011
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 30 Dec 2011 (estimated)
Results: Posted 12 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
62Cu-ETS PET assessment	Experimental	Drug: 150-Water, Drug: 62Cu-ethylglyoxal bis, Procedure: Positron Emission Tomography, Drug: SunitinibCT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information.
Patients with a diagnosis of relapsed Stage IV renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the PET/CT field-of-view that can include the heart.
Being considered for systemic therapy with Sunitinib

Key exclusion criteria (4 listed)

Women who are pregnant, breast-feeding, or of childbearing potential and not using birth control
Having no telephone or a reliable way in which study personal can contact them
Subjects who are claustrophobic and cannot tolerate imaging procedures
Subjects who weigh > 350 lb. (upper weight limit of scanner beds)

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
150-WaterPatients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.	Drug	62Cu-ETS PET assessment
62Cu-ethylglyoxal bisImaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV.	Drug	62Cu-ETS PET assessment
Positron Emission TomographyAlso: Seimens Biograph 64 TruePoint systemPET Scan	Procedure or surgery	62Cu-ETS PET assessment
Sunitinib	Drug	62Cu-ETS PET assessment

Primary outcome

Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
Time frame: Baseline
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET

1 secondary outcome

Maximum Standard Uptake Value (SUV) for Lesion Data
Time frame: Baseline and 14-28 days after initiation of Sunitinib

Results and safety

Results posted to the registry on 12 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
62Cu-ETS PET Assessment	14	13

Primary outcome: Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained

Time frame: Baseline. Count of participants. Unit: Participants

Measure	62Cu-ETS PET Assessment n = 14
Value	14

Population analysed: All Patients Enrolled.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
62Cu-ETS PET Assessment	0 of 14 (0%)	11 of 14 (78.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
09008-12(1011004283)-PT/CT Assessment of Tumor Perfusion in Patients with RCCLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Renal Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

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.

James Fletcher, M.D. principal investigator

Indiana University, Radiology

Theodore Logan, M.D. principal investigator

Indiana University, Dept. Medicine (Hem/Onc)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 150-Water, 62Cu-ethylglyoxal bis and Positron Emission Tomography in people with Renal Cell Carcinoma, run by Indiana University at 1 site in United States.

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 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: stopped early, as of the sponsor's last update on 5 Mar 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained (time frame: Baseline). 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 NCT01502228.

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 5 Mar 2019.