Hepatocellular CarcinomaPhase 2NCT02549755

11C-acetate for Treatment Response After Radiotherapy for HCC

A Phase 2 study testing 11C-Acetate in people with Hepatocellular Carcinoma, run by Justin Sims at 1 site in United States.

Terminated

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

Official record

Search all trials

Trial summary

It is thought that PET of the abdomen with 11C Acetate will provide new information regarding whether or not patient's have benefited from radiotherapy. To test this theory, the project will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of treatment success. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: 11C-Acetate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Oct 2016
Phase: Phase 2
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

> 18 years of age
Subject is willing to participate in the study and has signed the study informed consent
Subject is available and willing to comply with the protocol evaluations
Diagnosed hepatocellular carcinoma confined to a single lobe of the liver if undergoing 90Y radioembolization
Diagnosed hepatocellular carcinoma confined to the liver if undergoing Stereotactic Body Radiation Therapy (SBRT)
Under consideration for 90Y radioembolization or Stereotactic Body Radiation Therapy (SBRT)

Who cannot join

Pregnant or planning to become pregnant within the next 12 months or breast-feeding
GFR < 45
Life expectancy < 6 months
Claustrophobic and cannot tolerate imaging procedures
Weigh > 350 lb (upper weight limit of scanner beds)
Special vulnerabilities (e.g. fetuses, neonatales, pregnant women, children, prisoners, institutionalized individuals).

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Feasibility of 11C-acetate in the Monitoring of Treatment Response Following Radiotherapy in Patients With Hepatocellular Carcinoma

Conditions: Hepatocellular Carcinoma
Being tested: 11C-Acetate
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

11C-AcetateDrug
The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).
There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient

Study groups in NCT02549755
Study group	Role	What they receive
Radiotherapy treatment monitoring of hepatocellular carcinoma	Other	All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points. Receives: Drug: 11C-Acetate

What is being measured

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

To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.
Measured: At three months

Timeline

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

Sep 2015Oct 2016

First posted15 Sep 2015 (estimated)
Study startSep 2015
Primary completionOct 2016
Study completionOct 2016

Why it stopped: Poor enrollment

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.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02549755
Sponsor's protocol ID: IUSCC-0543
Status last verified: Oct 2017
First submitted: 11 Sep 2015
Last updated: 22 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dancey JE, Shepherd FA, Paul K, Sniderman KW, Houle S, Gabrys J, Hendler AL, Goin JE. Treatment of nonresectable hepatocellular carcinoma with intrahepatic 90Y-microspheres. J Nucl Med. 2000 Oct;41(10):1673-81.
PubMed 11037997
Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7.
PubMed 21645977
Forner A, Ayuso C, Varela M, Rimola J, Hessheimer AJ, de Lope CR, Reig M, Bianchi L, Llovet JM, Bruix J. Evaluation of tumor response after locoregional therapies in hepatocellular carcinoma: are response evaluation criteria in solid tumors reliable? Cancer. 2009 Feb 1;115(3):616-23. doi: 10.1002/cncr.24050.
PubMed 19117042
Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
PubMed 18477802
Riaz A, Miller FH, Kulik LM, Nikolaidis P, Yaghmai V, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Gupta R, Wang E, Baker T, Abecassis M, Benson AB 3rd, Nemcek AA Jr, Omary R, Salem R. Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma. JAMA. 2010 Mar 17;303(11):1062-9. doi: 10.1001/jama.2010.262.
PubMed 20233824
Keppke AL, Salem R, Reddy D, Huang J, Jin J, Larson AC, Miller FH. Imaging of hepatocellular carcinoma after treatment with yttrium-90 microspheres. AJR Am J Roentgenol. 2007 Mar;188(3):768-75. doi: 10.2214/AJR.06.0706.
PubMed 17312067
Krinsky GA, Lee VS, Theise ND, Weinreb JC, Rofsky NM, Diflo T, Teperman LW. Hepatocellular carcinoma and dysplastic nodules in patients with cirrhosis: prospective diagnosis with MR imaging and explantation correlation. Radiology. 2001 May;219(2):445-54. doi: 10.1148/radiology.219.2.r01ma40445.
PubMed 11323471
Peterson MS, Baron RL, Marsh JW Jr, Oliver JH 3rd, Confer SR, Hunt LE. Pretransplantation surveillance for possible hepatocellular carcinoma in patients with cirrhosis: epidemiology and CT-based tumor detection rate in 430 cases with surgical pathologic correlation. Radiology. 2000 Dec;217(3):743-9. doi: 10.1148/radiology.217.3.r00dc28743.
PubMed 11110938
Fendler WP, Philippe Tiega DB, Ilhan H, Paprottka PM, Heinemann V, Jakobs TF, Bartenstein P, Hacker M, Haug AR. Validation of several SUV-based parameters derived from 18F-FDG PET for prediction of survival after SIRT of hepatic metastases from colorectal cancer. J Nucl Med. 2013 Aug;54(8):1202-8. doi: 10.2967/jnumed.112.116426. Epub 2013 May 31.
PubMed 23729697
Verhoef C, Valkema R, de Man RA, Krenning EP, Yzermans JN. Fluorine-18 FDG imaging in hepatocellular carcinoma using positron coincidence detection and single photon emission computed tomography. Liver. 2002 Feb;22(1):51-6. doi: 10.1046/j.0106-9543.2001.01593.x.
PubMed 11906619
Khan MA, Combs CS, Brunt EM, Lowe VJ, Wolverson MK, Solomon H, Collins BT, Di Bisceglie AM. Positron emission tomography scanning in the evaluation of hepatocellular carcinoma. J Hepatol. 2000 May;32(5):792-7. doi: 10.1016/s0168-8278(00)80248-2.
PubMed 10845666
Trojan J, Schroeder O, Raedle J, Baum RP, Herrmann G, Jacobi V, Zeuzem S. Fluorine-18 FDG positron emission tomography for imaging of hepatocellular carcinoma. Am J Gastroenterol. 1999 Nov;94(11):3314-9. doi: 10.1111/j.1572-0241.1999.01544.x.
PubMed 10566736
Larsson P, Arvidsson D, Bjornstedt M, Isaksson B, Jersenius U, Motarjemi H, Jacobsson H. Adding 11C-acetate to 18F-FDG at PET Examination Has an Incremental Value in the Diagnosis of Hepatocellular Carcinoma. Mol Imaging Radionucl Ther. 2012 Apr;21(1):6-12. doi: 10.4274/Mirt.87. Epub 2012 Apr 1.
PubMed 23487415
Ho CL, Yu SC, Yeung DW. 11C-acetate PET imaging in hepatocellular carcinoma and other liver masses. J Nucl Med. 2003 Feb;44(2):213-21.
PubMed 12571212
Ho CL, Chen S, Yeung DW, Cheng TK. Dual-tracer PET/CT imaging in evaluation of metastatic hepatocellular carcinoma. J Nucl Med. 2007 Jun;48(6):902-9. doi: 10.2967/jnumed.106.036673. Epub 2007 May 15.
PubMed 17504862

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

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of 11C-acetate in the Monitoring of Treatment Response Following Radiotherapy in Patients With Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT02549755
Acronym / sponsor ID: IUSCC-0543
Conditions: Hepatocellular Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor enrollment
Enrolment: 1 participants (actual)
Lead sponsor: Justin SimsUniversity, hospital or other
Study start: Sep 2015 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 15 Sep 2015 (estimated)
Results: Posted 22 Nov 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Radiotherapy treatment monitoring of hepatocellular carcinoma	Other	Drug: 11C-AcetateAll patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points.

Who may qualify

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

Key inclusion criteria (6 listed)

> 18 years of age
Subject is willing to participate in the study and has signed the study informed consent
Subject is available and willing to comply with the protocol evaluations
Diagnosed hepatocellular carcinoma confined to a single lobe of the liver if undergoing 90Y radioembolization
Diagnosed hepatocellular carcinoma confined to the liver if undergoing Stereotactic Body Radiation Therapy (SBRT)

Key exclusion criteria (6 listed)

Pregnant or planning to become pregnant within the next 12 months or breast-feeding
GFR < 45
Life expectancy < 6 months
Claustrophobic and cannot tolerate imaging procedures
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
11C-AcetateThe 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq). There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient	Drug	Radiotherapy treatment monitoring of hepatocellular carcinoma

Primary outcome

To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
Time frame: At three months
The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.

Results and safety

Results posted to the registry on 22 Nov 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
Main Arm	1	0

Primary outcome: To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate

Time frame: At three months

Adverse events

Time frame: Adverse event data were collected during the period of observation of the participant immediately before, during, and after the single PET/CT scan.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Arm	0 of 1 (0%)	0 of 1 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11037997Dancey JE, Shepherd FA, Paul K, Sniderman KW, Houle S, Gabrys J, Hendler AL, Goin JE. Treatment of nonresectable hepatocellular carcinoma with intrahepatic 90Y-microspheres. J Nucl Med. 2000 Oct;41(10):1673-81.
Background: PubMed 21645977Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7.
Background: PubMed 19117042Forner A, Ayuso C, Varela M, Rimola J, Hessheimer AJ, de Lope CR, Reig M, Bianchi L, Llovet JM, Bruix J. Evaluation of tumor response after locoregional therapies in hepatocellular carcinoma: are response evaluation criteria in solid tumors reliable? Cancer. 2009 Feb 1;115(3):616-23. doi: 10.1002/cncr.24050.
Background: PubMed 18477802Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.
Background: PubMed 20233824Riaz A, Miller FH, Kulik LM, Nikolaidis P, Yaghmai V, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Gupta R, Wang E, Baker T, Abecassis M, Benson AB 3rd, Nemcek AA Jr, Omary R, Salem R. Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma. JAMA. 2010 Mar 17;303(11):1062-9. doi: 10.1001/jama.2010.262.
Background: PubMed 17312067Keppke AL, Salem R, Reddy D, Huang J, Jin J, Larson AC, Miller FH. Imaging of hepatocellular carcinoma after treatment with yttrium-90 microspheres. AJR Am J Roentgenol. 2007 Mar;188(3):768-75. doi: 10.2214/AJR.06.0706.
Background: PubMed 11323471Krinsky GA, Lee VS, Theise ND, Weinreb JC, Rofsky NM, Diflo T, Teperman LW. Hepatocellular carcinoma and dysplastic nodules in patients with cirrhosis: prospective diagnosis with MR imaging and explantation correlation. Radiology. 2001 May;219(2):445-54. doi: 10.1148/radiology.219.2.r01ma40445.
Background: PubMed 11110938Peterson MS, Baron RL, Marsh JW Jr, Oliver JH 3rd, Confer SR, Hunt LE. Pretransplantation surveillance for possible hepatocellular carcinoma in patients with cirrhosis: epidemiology and CT-based tumor detection rate in 430 cases with surgical pathologic correlation. Radiology. 2000 Dec;217(3):743-9. doi: 10.1148/radiology.217.3.r00dc28743.
Background: PubMed 23729697Fendler WP, Philippe Tiega DB, Ilhan H, Paprottka PM, Heinemann V, Jakobs TF, Bartenstein P, Hacker M, Haug AR. Validation of several SUV-based parameters derived from 18F-FDG PET for prediction of survival after SIRT of hepatic metastases from colorectal cancer. J Nucl Med. 2013 Aug;54(8):1202-8. doi: 10.2967/jnumed.112.116426. Epub 2013 May 31.
Background: PubMed 11906619Verhoef C, Valkema R, de Man RA, Krenning EP, Yzermans JN. Fluorine-18 FDG imaging in hepatocellular carcinoma using positron coincidence detection and single photon emission computed tomography. Liver. 2002 Feb;22(1):51-6. doi: 10.1046/j.0106-9543.2001.01593.x.
Background: PubMed 10845666Khan MA, Combs CS, Brunt EM, Lowe VJ, Wolverson MK, Solomon H, Collins BT, Di Bisceglie AM. Positron emission tomography scanning in the evaluation of hepatocellular carcinoma. J Hepatol. 2000 May;32(5):792-7. doi: 10.1016/s0168-8278(00)80248-2.
Background: PubMed 10566736Trojan J, Schroeder O, Raedle J, Baum RP, Herrmann G, Jacobi V, Zeuzem S. Fluorine-18 FDG positron emission tomography for imaging of hepatocellular carcinoma. Am J Gastroenterol. 1999 Nov;94(11):3314-9. doi: 10.1111/j.1572-0241.1999.01544.x.

Related trials for Hepatocellular Carcinoma

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract 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.

Justin B Sims, MD principal investigator

Indiana University

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 11C-Acetate in people with Hepatocellular Carcinoma, run by Justin Sims 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 6 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: stopped early, as of the sponsor's last update on 22 Nov 2017. 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.

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?

Yes. Results are posted in the registry (first posted 22 Nov 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?

To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate (time frame: At three months). 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 NCT02549755, which also lists 27 linked publications.

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 22 Nov 2017.