Liver CancerPhase 2NCT01877187

Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer

A Phase 2 study testing Lipiodol in people with Liver Cancer, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Cancer
What is being tested?: Lipiodol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 2 sitesUnited States
Study dates: Apr 2013to Feb 2020
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 or older.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Childs class of A or B (up to 9).
Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or subject has HCC and refused surgery or subject is diagnosed hepatic metastases from any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC).
Subject is voluntarily participating in the study and has signed the informed consent.

Who cannot join

Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or specific mixture of chemotherapy drugs to be used).
Evidence of severe or uncontrolled systemic diseases.
Congestive cardiac failure >NYHA class 2 MI within 6 months, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, unstable angina, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents (that cannot be adequately mitigated with pre-procedure medication).
Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis is acceptable.
Subject is breastfeeding.
Subject is pregnant

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Smilow Cancer Center
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer

The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of liver function and tumor markers).

Conditions: Liver Cancer
Being tested: Lipiodol
Keywords: Primary liver cancer, Metastatic liver cancer
Medical subject headings: Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

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

LipiodolDrug
Also called Ethiodol
Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).

Study groups in NCT01877187
Study group	Role	What they receive
Lipiodol	Other	Lipiodol, 10cc per TACE. Receives: Drug: Lipiodol

What is being measured

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

Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:
Complete Response (CR): Disappearance of all target lesions Partial Response (PR): >= 30% decrease in the sum of the longest diameter of target lesions
Overall Response (OR) = CR + PR
Measured: 30 days, 90 days, and 180 days
Baseline Enhancing Tumor and Response by RECIST Criteria
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by RECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by RECIST criteria. Nonresponders are all other subjects.
Measured: 30 days, 90 days, 180 days

Secondary outcomes (9)

Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with mRECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per modified Response Evaluation Criteria in Solid Tumors (mRECIST):
Complete Response (CR): Disappearance of all intratumoral arterial enhancement in target lesions Partial Response (PR): At least 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions Overall Response (OR) = CR + PR
Measured: 30 days, 90 days, and 180 days
Baseline Enhancing Tumor and Response by mRECIST Criteria
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by mRECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by mRECIST criteria. Nonresponders are all other subjects.
Measured: 30 days, 90 days, 180 days
Tumor Response by World Health Organization (WHO) Criteria
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with WHO response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per WHO criteria:
Complete Response (CR): disappearance of all lesions for >= 4 weeks. Partial Response (PR): At least 50% decrease in sum of the products of diameters of target lesions.
Overall Response: CR + PR.
Measured: 6 months
Baseline Enhancing Tumor and Response by WHO Criteria
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by WHO criteria. Responders are subjects that demonstrated Complete Response or Partial Response by WHO criteria. Nonresponders are all other subjects.
Measured: 30 days, 90 days, 180 days
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with EASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per EASL response:
Complete Response (CR): complete disappearance of enhancing tissue in target lesions Partial Response (PR): At least 50% decrease in area of enhancing tissue in target lesions.
Overall Response: CR+PR
Measured: 6 months
Baseline Enhancing Tumor and Response by EASL Criteria
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by EASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by EASL criteria. Nonresponders are all other subjects.
Measured: 30 days, 90 days, 180 days
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with qEASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per qEASL criteria:
Complete Response (CR): Total disappearance of enhancing tumor volume in target lesions Partial Response (PR): At least 65% decrease in enhanced tumor volume after treatment.
Overall Response: CR + PR
Measured: 6 months
Baseline Enhancing Tumor and Response by qEASL Criteria
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by qEASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by qEASL criteria. Nonresponders are all other subjects.
Measured: 30 days, 90 days, 180 days
6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE
Measure the association between baseline Lipiodol deposition and the 6-month survival rate by estimating median survival for each stratum, and by testing for homogeneity using a logrank test if hazards are proportional.
Measured: 6 months

Timeline

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

Apr 2013Feb 2020

First posted13 Jun 2013 (estimated)
Study startApr 2013
Primary completionFeb 2020
Study completionFeb 2020

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 Liver CancerStudies of the same condition, open and under way.
More trials run by Yale 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 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01877187
Sponsor's protocol ID: J12115
Other IDs: NA_00074005, HIC1601017054
Status last verified: Apr 2020
First submitted: 27 Mar 2013
Last updated: 15 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

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All Liver Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer
ClinicalTrials.gov ID: NCT01877187
Acronym / sponsor ID: J12115
Conditions: Liver Cancer
Keywords: Primary liver cancer, Metastatic liver cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Guerbet
Study start: Apr 2013 (actual)
Primary completion: Feb 2020 (actual)
Study completion: Feb 2020 (actual)
First posted: 13 Jun 2013 (estimated)
Results: Posted 15 Apr 2020

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
Lipiodol	Other	Drug: LipiodolLipiodol, 10cc per TACE.

Who may qualify

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

Key inclusion criteria (5 listed)

18 years of age or older.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Childs class of A or B (up to 9).
Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or subject has HCC and refused surgery or subject is diagnosed hepatic metastases from any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC).
Subject is voluntarily participating in the study and has signed the informed consent.

Key exclusion criteria (7 listed)

Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or specific mixture of chemotherapy drugs to be used).
Evidence of severe or uncontrolled systemic diseases.
Congestive cardiac failure >NYHA class 2 MI within 6 months, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, unstable angina, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents (that cannot be adequately mitigated with pre-procedure medication).
Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis is acceptable.

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
LipiodolAlso: EthiodolLipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).	Drug	Lipiodol

Primary outcome

Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 30 days, 90 days, and 180 days
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): >= 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR
Baseline Enhancing Tumor and Response by RECIST Criteria
Time frame: 30 days, 90 days, 180 days
Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by RECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by RECIST criteria. Nonresponders are all other subjects.

9 secondary outcomes

Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time frame: 30 days, 90 days, and 180 days
Baseline Enhancing Tumor and Response by mRECIST Criteria
Time frame: 30 days, 90 days, 180 days
Tumor Response by World Health Organization (WHO) Criteria
Time frame: 6 months
Baseline Enhancing Tumor and Response by WHO Criteria
Time frame: 30 days, 90 days, 180 days
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
Time frame: 6 months
Baseline Enhancing Tumor and Response by EASL Criteria
Time frame: 30 days, 90 days, 180 days
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
Time frame: 6 months
Baseline Enhancing Tumor and Response by qEASL Criteria
Time frame: 30 days, 90 days, 180 days
6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE
Time frame: 6 months

Results and safety

Results posted to the registry on 15 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lipiodol	39	17

Primary outcome: Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)

Time frame: 30 days, 90 days, and 180 days. Count of participants. Unit: Participants

Measure	Lipiodol (HCC) n = 18	Lipiodol (Non-HCC) n = 16
30 day f/u: Responders	1	1
30 day f/u: Non-responders	17	15
90 day f/u: Responders	5	3
90 day f/u: Non-responders	6	4
180 day f/u: Responders	4	2
180 day f/u: Non-responders	7	3

Population analysed: 18 HCC and 16 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.

Primary outcome: Baseline Enhancing Tumor and Response by RECIST Criteria

Time frame: 30 days, 90 days, 180 days. Median (Full Range). Unit: % tumor enhancement

Measure	Lipiodol (HCC) n = 16	Lipiodol (Non-HCC) n = 14	Overall n = 30
(30 day) Responders	95.1 (95.1 to 95.1)	97.30 (97.3 to 97.3)	96.2 (95.1 to 97.3)
(30 day) Nonresponders	53.4 (6.1 to 99.8)	50.7 (6.0 to 81.9)	52.1 (6.0 to 99.8)
(90 day) Responders	65.2 (29.6 to 99.8)	89.6 (81.9 to 97.3)	79.4 (29.6 to 99.8)
(90 day) Nonresponders	50.6 (36.3 to 93.4)	30.4 (6.0 to 67.8)	42.4 (6.0 to 93.4)
(180 day) Responders	77.0 (53.4 to 99.8)	89.6 (81.9 to 97.3)	81.9 (53.4 to 99.8)
(180 day) Nonresponders	46.2 (29.6 to 93.4)	43.1 (18.4 to 67.8)	46.2 (18.4 to 93.4)

Overall: p = .06, Wilcoxon (Mann-Whitney)
Overall: p = .09, Wilcoxon (Mann-Whitney)
Overall: p = 0.034, Wilcoxon (Mann-Whitney)

Population analysed: 16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months post treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lipiodol/TACE	11 of 39 (28.2%)	33 of 39 (84.6%)	2 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Todd Schlachter, MD principal investigator

Yale University

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lipiodol in people with Liver Cancer, run by Yale University at 2 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 15 Apr 2020). 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?

Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: 30 days, 90 days, and 180 days). 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?

On the ClinicalTrials.gov record for NCT01877187.

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 15 Apr 2020.