Liver MetastasesPhase 1NCT03029988

An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.

A Phase 1 study testing Tilmanocept (Technetium Tc 99m tilmanocept Injection) and SPECT/CT Imaging in people with Liver Metastases and Colorectal Carcinoma, run by Navidea Biopharmaceuticals 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

Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Metastases, Colorectal Carcinoma
What is being tested?: Tilmanocept (Technetium Tc 99m tilmanocept Injection) and SPECT/CT Imaging
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2017to 24 Sep 2018
Phase: Phase 1
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

The subject has provided written informed consent with Health Information Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
Subjects must be ≥18 years old;
The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with FDG PET/CT confirmed metastases to the liver;
The subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
The subject must be at least 4 weeks past any major intraabdominal surgery, including surgery to the liver;
Subjects with prior malignancies other than colon and/or rectum cancer are allowed, provided they have been treated with curative intent, and have no evidence of recurrence of that malignancy;
Each subject must have no more than 10 qualifying liver lesions that have been clinically confirmed metastatic adenocarcinoma of the colon by FDG PET/CT imaging.
If of childbearing potential, the subject has a negative urine pregnancy test within 48 hours before administration of Tc 99m Tilmanocept, has been surgically sterilized, or has been postmenopausal for at least 1 year

Who cannot join

The subject is pregnant or lactating.
The subject has undergone any liver surgery, exclusive of a biopsy.
The subject has known sensitivity to dextran.
The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 10 days prior to Tc 99m Tilmanocept administration
Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
Has received an investigational product within the 30 days prior to Tc 99m Tilmanocept administration

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama Birmingham
Birmingham, Alabama, 35249

Other trials in United States

About this study

Official title: An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECT/CT Imaging Compared to Fluorodeoxyglucose (FDG) PET/CT Imaging.

Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.

Read the detailed description

This is a prospective, open-label, single-center, comparator study of IV injected Tc 99m Tilmanocept in the localization and detection of liver metastases in subjects with confirmed colorectal carcinoma (CRC). The study will be divided into two cohorts.

If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data.

This study is designed to evaluate the safety and tolerability of Tc 99m tilmanocept administered intravenously. SPECT/CT imaging of the subject's abdominal cavity will be reviewed to establish concordance with FDG PET imaging.

Conditions: Liver Metastases, Colorectal Carcinoma
Being tested: Tilmanocept (Technetium Tc 99m tilmanocept Injection), SPECT/CT Imaging
Keywords: adenocarcinoma, Colorectal Carcinoma, liver metastases
Medical subject headings: Colorectal Neoplasms, Adenocarcinoma

What participants receive

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

Tilmanocept (Technetium Tc 99m tilmanocept Injection)Drug
Also called Lymphoseek
Drug: Technetium Tc 99m tilmanocept
SPECT/CT ImagingProcedure or surgery
4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.

Study groups in NCT03029988
Study group	Role	What they receive
Cohort 1	Experimental	Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection. Receives: Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection); Procedure: SPECT/CT Imaging
Cohort 2	Experimental	Subjects will receive 200 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection. If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data. Receives: Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection); Procedure: SPECT/CT Imaging

What is being measured

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

Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.
The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.
Measured: Within 7 days after Tc 99m tilmanocept administration

Timeline

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

26 Jul 201724 Sep 2018

First posted24 Jan 2017 (estimated)
Study start26 Jul 2017
Primary completion24 Sep 2018
Study completion24 Sep 2018

Why it stopped: Lack of effect in Cohort 1

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 MetastasesStudies 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 1
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Model description: Injection and imaging will begin with Cohort 1. Cohort 1 and Cohort 2 will receive tilmanocept intravenously.
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03029988
Sponsor's protocol ID: NAV3-25
Other IDs: 1R44CA162783-01
Status last verified: Sep 2020
First submitted: 20 Jan 2017
Last updated: 10 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
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

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All Liver Metastases trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECT/CT Imaging Compared to Fluorodeoxyglucose (FDG) PET/CT Imaging.
ClinicalTrials.gov ID: NCT03029988
Acronym / sponsor ID: NAV3-25
Conditions: Liver Metastases, Colorectal Carcinoma
Keywords: adenocarcinoma, Colorectal Carcinoma, liver metastases
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of effect in Cohort 1
Enrolment: 3 participants (actual)
Lead sponsor: Navidea BiopharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Study start: 26 Jul 2017 (actual)
Primary completion: 24 Sep 2018 (actual)
Study completion: 24 Sep 2018 (actual)
First posted: 24 Jan 2017 (estimated)
Results: Posted 18 Nov 2019

Clinical summary

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

Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Injection and imaging will begin with Cohort 1. Cohort 1 and Cohort 2 will receive tilmanocept intravenously.

Arm	Type	Receives
Cohort 1	Experimental	Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection), Procedure: SPECT/CT ImagingSubjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection.
Cohort 2	Experimental	Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection), Procedure: SPECT/CT ImagingSubjects will receive 200 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection. If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data.

Who may qualify

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

Key inclusion criteria (8 listed)

The subject has provided written informed consent with Health Information Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
Subjects must be ≥18 years old;
The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with FDG PET/CT confirmed metastases to the liver;
The subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
The subject must be at least 4 weeks past any major intraabdominal surgery, including surgery to the liver;

Key exclusion criteria (6 listed)

The subject is pregnant or lactating.
The subject has undergone any liver surgery, exclusive of a biopsy.
The subject has known sensitivity to dextran.
The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 10 days prior to Tc 99m Tilmanocept administration
Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical

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
Tilmanocept (Technetium Tc 99m tilmanocept Injection)Also: LymphoseekDrug: Technetium Tc 99m tilmanocept	Drug	Cohort 1, Cohort 2
SPECT/CT Imaging4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.	Procedure or surgery	Cohort 1, Cohort 2

Primary outcome

Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.
Time frame: Within 7 days after Tc 99m tilmanocept administration
The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.

Results and safety

Results posted to the registry on 18 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	3	3

Primary outcome: Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.

Time frame: Within 7 days after Tc 99m tilmanocept administration. Number. Unit: Lesions

Measure	Cohort 1 - FDG PET CT n = 3	Cohort 1 - Tilmanocept SPECT/CT n = 3
Liver	7	0
Colon	1	0

Adverse events

Time frame: 35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Limitations and caveats (from the sponsor): Early termination leading to small number of subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Liver Metastases

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
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Not yet recruitingPhase 2
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Active, not recruitingPhase 1
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Recruiting
CREO - Microwave Ablation Feasibility Study
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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.

Frederick O Cope, PhD principal investigator

Navidea Biopharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

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 8 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 10 Sep 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 18 Nov 2019). 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?

Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging. (time frame: Within 7 days after Tc 99m tilmanocept administration). 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 NCT03029988.

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 10 Sep 2020.