Ovarian CancerPhase 1NCT01689636
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients
A Phase 1 study testing Tc 99m EC20 in people with Ovarian Cancer and Healthy Volunteers, run by Endocyte at 1 site in United States.
Trial summary
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Healthy Volunteers
- What is being tested?
- Tc 99m EC20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jul 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects were to be females 18 years of age or older who met the following criteria:
- The four normal subjects were to be normal, as established by medical history, physical examination, and laboratory data, including CBC, serum chemistry, and urinalysis.
- The two subjects with obvious advanced stage ovarian cancer were to have either histopathologically proven stage 3 or 4 disease or clinically obvious disease defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental "caking", or (3) ascites.
- Subjects were to have newly diagnosed, treatment refractory, or recurrent disease. Subjects were to be treatment naïve or at least 2 months since last non-surgical treatment. Subjects were to have normal kidney and liver function.
- The two subjects with suspected ovarian cancer were to have a known mass. Subjects were to have normal kidney and liver function.
- Subjects were to provide informed consent prior to enrollment.
Who cannot join
- The following subjects were to be excluded:
- Subject was pregnant or breast-feeding.
- Subject was simultaneously participating in another investigative drug or device study, or had completed follow-up phase of any previous study within 30 days prior to enrollment in this study.
- Subject had a known history of chronic abuse of drugs or alcohol or had tested positive in the pre-study urine drug abuse screen.
- Subject was currently taking folic acid supplements and could not stop taking the supplements for a period of 3 days (2 days prior to the study and one day after last imaging procedure).
- Subject had physical condition that was unsuitable for radionuclide imaging.
- Subject had been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of Technetium Tc 99m EC20.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical Center
St Louis, Missouri
About this study
Official title: CLINICAL STUDY OF A SINGLE-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND BIODISTRIBUTION OF TECHNETIUM Tc 99m EC20 IN NORMAL VOLUNTEERS AND OVARIAN CANCER PATIENTS
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer.
Read the detailed description
This was a single-center, open-label evaluation of a single injection of Tc 99m EC20 containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and patients with known or suspected ovarian cancer. Two normal volunteers and two patients also were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour period following each injection for pharmacokinetic evaluation. Serial whole body images were acquired during the 24-hour postdose period for dosimetry evaluations. Safety was monitored through predose and postdose physical examinations, electrocardiograms (ECGs), vital signs and clinical laboratory evaluations. Adverse events were monitored from the time of signing of Informed Consent to 24 hours postdose.
- Conditions
- Ovarian Cancer, Healthy Volunteers
- Being tested
- Tc 99m EC20
- Keywords
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc 99m EC20Drug
| Study group | Role | What they receive |
|---|---|---|
| Single-center, open-label | Experimental | The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer.
Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20. Receives: Drug: Tc 99m EC20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startAug 2000
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocyte
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689636
- Sponsor's protocol ID
- EC20.1
- Status last verified
- Jun 2023
- First submitted
- 9 Sep 2012
- Last updated
- 22 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL STUDY OF A SINGLE-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND BIODISTRIBUTION OF TECHNETIUM Tc 99m EC20 IN NORMAL VOLUNTEERS AND OVARIAN CANCER PATIENTS
- ClinicalTrials.gov ID
- NCT01689636
- Acronym / sponsor ID
- EC20.1
- Conditions
- Ovarian Cancer, Healthy Volunteers
- Keywords
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EndocyteIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Study completion
- Jul 2002 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer.
Detailed description
This was a single-center, open-label evaluation of a single injection of Tc 99m EC20 containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and patients with known or suspected ovarian cancer. Two normal volunteers and two patients also were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour period following each injection for pharmacokinetic evaluation. Serial whole body images were acquired during the 24-hour postdose period for dosimetry evaluations. Safety was monitored through predose and postdose physical examinations, electrocardiograms (ECGs), vital signs and clinical laboratory evaluations. Adverse events were monitored from the time of signing of Informed Consent to 24 hours postdose.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-center, open-label | Experimental | Drug: Tc 99m EC20The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer. Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects were to be females 18 years of age or older who met the following criteria:
Key exclusion criteria (7 listed)
- The following subjects were to be excluded:
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 |
|---|---|---|
| Tc 99m EC20 | Drug | Single-center, open-label |
Primary outcome
Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tc 99m EC20 in people with Ovarian Cancer and Healthy Volunteers, run by Endocyte 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 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 22 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2023.