Metastatic SarcomaPhase 1/2PHANTOMNCT06298916
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
A Phase 1/2 study testing 64Cu-LNTH-1363S in people with Metastatic Sarcoma and Esophageal Cancer, run by Lantheus Medical Imaging at 5 sites in United States.
Trial summary
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Metastatic Sarcoma, Esophageal Cancer, Gastric Cancer
- What is being tested?
- 64Cu-LNTH-1363S
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2025to Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients are eligible to be included in the study only if all of the following criteria apply:
- Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to <18 years must weigh at least 55 kg.
- Patients with suspected FAP-expressing metastatic sarcoma.
- Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).
- Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.
- Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
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- Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
- Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.
- Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to <18 years must weigh at least 55 kg.
- Patients must have histological, pathological, and/or cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer.
- Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging).
- Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging.
- Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
- Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
- Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.
Who cannot join
- Patients are excluded from the study if any of the following criteria apply:
- Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.
- Known pregnancy or breastfeeding.
- Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
- Patients participating in another clinical trial at the time of screening for this study.
- Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.
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- Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
- History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, > 450 milliseconds) or taking medication known to cause QT/QTc prolongation.
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.
- Evidence of metastatic or advanced, inoperable disease.
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.
- Known pregnancy or breastfeeding.
- Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
- Patients participating in another clinical trial at the time of screening for this study.
- Has undergone or plans to undergo PET or SPECT imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
- History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, > 450 milliseconds) or taking drugs known to cause QT/QTc prolongation.
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Brian Turpin, MD, 1-513-636-2799, cancer@cchmc.org
Brian Turpin, MD
- Recruiting
City of Hope
Duarte, California, 91010
Jessica Liu, Clinical Research Nurse, (626)218-0473, Jesliu@coh.org
Yufei Liu, MD
- Recruiting
BAMF Health, Inc.
Grand Rapids, Michigan, 49503
Kevin Quinn, 616-330-2735, researchclinicalteam@bamfhealth.com
Harshad Kulkarni, MD
- Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868
Shyam Srinivas, MD, PhD, 877-827-8839, ucstudy@uci.edu
Shyam Srinivas, MD, PhD
- Recruiting
Stanford Hospital & Clinics
Stanford, California, 94305
Mikayla Easterling, 650-724-3698, maeast@stanford.edu
Farshad Moradi, MD
About this study
Official title: A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).
Read the detailed description
Part 1 will determine the biodistribution, dosimetry, optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S in 6 evaluable patients with supposed FAP-expressing solid tumors (metastatic sarcomas). All six patients will receive 8 ± 1 mCi (~90 μg mass dose) in this study. All images will undergo analysis by blinded central readers. Optimal radioactivity and timing window will be determined based on image quality scores and measured tumor-to-background ratio. Part 1 of the study will last approximately 3 weeks for each patient and includes a Screening Period (up to 14 days), a 1-day Intervention Period and a Safety Follow-up Period (7 days post dose).
Part 2 will evaluate 64Cu-LNTH-1363S correlation with FAP expression measured by IHC (SUVmax and SUVmean vs IHC score) in 20 evaluable patients with non-metastatic, operable, supposed FAP-expressing solid tumors (sarcomas, esophageal, gastric, pancreatic, colorectal) planned for surgery within 60 days (from study imaging). If the optimal radioactivity determined from Part 1 is less than 8 ± 1 mCi, the first 6 patients in Part 2 will be used to validate this optimal radioactivity.
Part 2 of the study will last approximately 10 to 11 weeks and includes: a Screening Period (up to 14 days), a 1-day Intervention Period, a 1 day Safety Followup Period (Day 2) and a Scheduled Surgery IHC Sample Collection Period (from Day 2 to Day 60).
Both Part 1 and Part 2 of the study will also monitor cardiac safety by detecting changes in HR, T wave, ST segment and other ECG parameters and characterizing the concentration-response relationship of 64Cu-LNTH-1363S for QT and corrected QT interval (QTc) prolongation.
- Conditions
- Metastatic Sarcoma, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer, Sarcoma
- Being tested
- 64Cu-LNTH-1363S
- Keywords
- FAPi, Imaging, 64Cu-LNTH-1363S
- Medical subject headings
- Sarcoma, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-LNTH-1363SCombination product
64Cu-LNTH-1363S, is a highly selective, high affinity FAP inhibitor (FAPi) that is radiolabeled with Copper-64 (64Cu) for PET/CT Imaging,
| Study group | Role | What they receive |
|---|---|---|
| Experimental Part 1 | Experimental | 6 patients will receive 8 ± 1 mCi (~90 μg mass dose) of the 64Cu-LNTH-1363S on Day 1 in the Intervention Period (raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with 6 mCi and 4 mCi 64Cu injected activities). Receives: Combination Product: 64Cu-LNTH-1363S |
| Experimental Part 2 | Experimental | First 6 evaluable patients will receive the optimal radioactivity determined in Part 1. The remaining 14 evaluable patients will receive either the optimal radioactivity determined in Part 1 (if the sum of the average image quality scores of the first 6 patients is higher or equal to 10.5), or 8 ± 1 mCi (if the sum of the average image quality scores of the first 6 patients is less than 10.5). Receives: Combination Product: 64Cu-LNTH-1363S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Part 1 Biodistribution of 64Cu-LNTH-1363S
Time Activity Curves (TACs) describing percentage of the injected activity versus time will be derived for selected organs and tumor lesions and absorbed radiation doses of 64Cu-LNTH-1363S in critical organs (e.g., kidneys, liver) will be estimated.
Measured: During serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.
Primary Part 1 - Optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S
Optimal dose (radioactivity) and imaging time window will be determined by using image quality scores from blinded central reviews. Each patient will receive 8 ± 1 mCi of 64Cu-LNTH-1363S. The raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with lower injected activities (6 mCi and 4 mCi).
Measured: During serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.
Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression
Correlation of 64Cu-LNTH-1363S biodistribution with FAP expression by IHC (SUVmean and SUVmax vs IHC score) and compare to circulating FAP in blood as analyzed by ELISA method.
Measured: Post surgery tissue collection to end of study
Secondary outcomes (4)
Secondary Parts 1 and 2 Safety and Tolerability
Safety and tolerability profile of 64Cu-LNTH-1363S in patients with sarcoma and GITs based on:
- Frequency and severity of adverse events (AEs) and serious AEs (SAEs) measured by Common Terminology Criteria for AEs (CTCAE) v5.0 or higher.
- Changes in vital signs
- Changes in laboratory parameters
- Changes in electrocardiogram (ECG)parameters
- Exposure-response relationships:
- Relationship of AEs to exposure (dose and concentrations).
Measured: Part1: From IP administration until the Day 7 (± 1 day) telephone follow up. Part 2: From time of IP administration to until post-surgery IHC sample collection.
Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma
Correlation of 64Cu-LNTH-1363S biodistribution with FAP expression by immunohistochemistry (IHC) (SUVmean and SUVmax vs IHC score) and compare to circulating FAP in blood as analyzed by ELISA method.
Measured: From Day 1 until the end of the Scheduled Surgery: IHC sample collection
Secondary Part 1 and Part 2 Cardiac Safety
Monitor cardiac safety and look for signals suggesting a concentration-response relationship of 64Cu-LNTH-1363S for QT/corrected QT interval (QTc) prolongation.
Measured: Continuous ECG monitoring at Visit 2
Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer
Validate optimal radioactivity in patients with sarcoma or GIT cancer, if the optimal radioactivity determined in Part 1 is less than 8 ± 1 mCi. Validation to be completed on image quality score of first 6 patients, if optimal radioactivity determined in Part 1 is less than 8 ± 1 mCi.
Measured: From start of Part 2 to 6 patients enrolled with qualifying imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study startAug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic SarcomaStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1: Metastatic Sarcoma Part 2: Non-metastatic sarcoma or gastrointestinal tract (GIT) cancer (esophageal, gastric, pancreatic, colorectal cancer)
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298916
- Sponsor's protocol ID
- FAPi-1301
- Acronym
- PHANTOM
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)
- ClinicalTrials.gov ID
- NCT06298916
- Acronym / sponsor ID
- PHANTOM / FAPi-1301
- Conditions
- Metastatic Sarcoma, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer, Sarcoma
- Keywords
- FAPi, Imaging, 64Cu-LNTH-1363S
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- 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.
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).
Detailed description
Part 1 will determine the biodistribution, dosimetry, optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S in 6 evaluable patients with supposed FAP-expressing solid tumors (metastatic sarcomas). All six patients will receive 8 ± 1 mCi (~90 μg mass dose) in this study. All images will undergo analysis by blinded central readers. Optimal radioactivity and timing window will be determined based on image quality scores and measured tumor-to-background ratio. Part 1 of the study will last approximately 3 weeks for each patient and includes a Screening Period (up to 14 days), a 1-day Intervention Period and a Safety Follow-up Period (7 days post dose).
Part 2 will evaluate 64Cu-LNTH-1363S correlation with FAP expression measured by IHC (SUVmax and SUVmean vs IHC score) in 20 evaluable patients with non-metastatic, operable, supposed FAP-expressing solid tumors (sarcomas, esophageal, gastric, pancreatic, colorectal) planned for surgery within 60 days (from study imaging). If the optimal radioactivity determined from Part 1 is less than 8 ± 1 mCi, the first 6 patients in Part 2 will be used to validate this optimal radioactivity.
Part 2 of the study will last approximately 10 to 11 weeks and includes: a Screening Period (up to 14 days), a 1-day Intervention Period, a 1 day Safety Followup Period (Day 2) and a Scheduled Surgery IHC Sample Collection Period (from Day 2 to Day 60).
Both Part 1 and Part 2 of the study will also monitor cardiac safety by detecting changes in HR, T wave, ST segment and other ECG parameters and characterizing the concentration-response relationship of 64Cu-LNTH-1363S for QT and corrected QT interval (QTc) prolongation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1: Metastatic Sarcoma Part 2: Non-metastatic sarcoma or gastrointestinal tract (GIT) cancer (esophageal, gastric, pancreatic, colorectal cancer)
| Arm | Type | Receives |
|---|---|---|
| Experimental Part 1 | Experimental | Combination Product: 64Cu-LNTH-1363S6 patients will receive 8 ± 1 mCi (~90 μg mass dose) of the 64Cu-LNTH-1363S on Day 1 in the Intervention Period (raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with 6 mCi and 4 mCi 64Cu injected activities). |
| Experimental Part 2 | Experimental | Combination Product: 64Cu-LNTH-1363SFirst 6 evaluable patients will receive the optimal radioactivity determined in Part 1. The remaining 14 evaluable patients will receive either the optimal radioactivity determined in Part 1 (if the sum of the average image quality scores of the first 6 patients is higher or equal to 10.5), or 8 ± 1 mCi (if the sum of the average image quality scores of the first 6 patients is less than 10.5). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients are eligible to be included in the study only if all of the following criteria apply:
- Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to <18 years must weigh at least 55 kg.
- Patients with suspected FAP-expressing metastatic sarcoma.
- Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).
- Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.
Key exclusion criteria (18 listed)
- Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.
- Known pregnancy or breastfeeding.
- Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
- Patients participating in another clinical trial at the time of screening for this study.
- Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.
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 |
|---|---|---|
| 64Cu-LNTH-1363S64Cu-LNTH-1363S, is a highly selective, high affinity FAP inhibitor (FAPi) that is radiolabeled with Copper-64 (64Cu) for PET/CT Imaging, | Combination product | Experimental Part 1, Experimental Part 2 |
Primary outcome
Primary Part 1 Biodistribution of 64Cu-LNTH-1363S
Time frame: During serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.
Time Activity Curves (TACs) describing percentage of the injected activity versus time will be derived for selected organs and tumor lesions and absorbed radiation doses of 64Cu-LNTH-1363S in critical organs (e.g., kidneys, liver) will be estimated.
Primary Part 1 - Optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S
Time frame: During serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.
Optimal dose (radioactivity) and imaging time window will be determined by using image quality scores from blinded central reviews. Each patient will receive 8 ± 1 mCi of 64Cu-LNTH-1363S. The raw data of each patient PET scan will be re-processed using a computer program to simulate scans of the same patient with lower injected activities (6 mCi and 4 mCi).
Primary Part 2 - Correlation of 64Cu-LNTH-1363S biodistribution with Immunohistochemistry FAP expression
Time frame: Post surgery tissue collection to end of study
Correlation of 64Cu-LNTH-1363S biodistribution with FAP expression by IHC (SUVmean and SUVmax vs IHC score) and compare to circulating FAP in blood as analyzed by ELISA method.
4 secondary outcomes
Secondary Parts 1 and 2 Safety and Tolerability
Time frame: Part1: From IP administration until the Day 7 (± 1 day) telephone follow up. Part 2: From time of IP administration to until post-surgery IHC sample collection.
Secondary Part 1 FAP expression profile of 64Cu-LNTH-1363S in patients with sarcoma
Time frame: From Day 1 until the end of the Scheduled Surgery: IHC sample collection
Secondary Part 1 and Part 2 Cardiac Safety
Time frame: Continuous ECG monitoring at Visit 2
Secondary Part 2 Validate optimal radioactivity in patients with sarcoma or GIT cancer
Time frame: From start of Part 2 to 6 patients enrolled with qualifying imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 64Cu-LNTH-1363S in people with Metastatic Sarcoma and Esophageal Cancer, run by Lantheus Medical Imaging at 5 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 15 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eryn Bagley (978-671-8886, clinicaltrials@lantheus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Part 1 Biodistribution of 64Cu-LNTH-1363S (time frame: During serial PET/CT scans taken on Day 1 at the following timepoints at 0.5 hour ± 10 minutes, 1 hour ±10 minutes, 2 hours ± 15 minutes, 4 to 6 hours, and 24 hours ± 4 hours post study intervention administration.). The study lists 3 primary outcomes in all. 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 12 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.