Non-Hodgkin's LymphomaEarly Phase 1NCT01269593
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
A Early Phase 1 study testing PET Imaging using 124 IPUH71 in people with Non-Hodgkin's Lymphoma and Myeloma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body \& inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Myeloma, Active Solid Malignancy
- What is being tested?
- PET Imaging using 124 IPUH71
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2026
- Phase
- Early Phase 1
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)
- Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or other tumor response criteria from an MSKCC IRB-approved clinical research protocol.
- This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).
- Age between 18-90
- Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential
- No breast-feeding
Who cannot join
- Previous allergic reaction to contrast medium.
- Hypersensitivity to iodide products.
- Known hyperthyroidism
- Hepatic:
- Bilirubin > 1.5 x institutional upper limit of normal (ULN)
- AST/ALT >2.5 x ULN
Show all 10Show fewer
- Albumin < 2 g/dl
- GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN. Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.
- Positive serum pregnancy test for females
- Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body \& inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.
- Conditions
- Non-Hodgkin's Lymphoma, Myeloma, Active Solid Malignancy
- Being tested
- PET Imaging using 124 IPUH71
- Keywords
- PET Scan, 124I-PUH71, 10-139
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Imaging using 124 IPUH71Drug
Also called Blood will be drawn at the multiple time points for pharmacokinetic & metabolite, analyses of 124I-PUH71. We anticipate these time points to be: approximately 10, minutes, 20 minutes, 30 minutes, 1-2 H, and 3-4 H, post-injection. Blood, samples will be obtained in the PET imaging suite.
A dose of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71 will be administered intravenously with the patient at rest. 124I-PUH71 scans will be performed at immediately and/or 3-4 hours, 20-24 hours, and 40-80 hours after injection of the radiotracer. Optionally, in willing patients scans will be performed 160-200 hours (~7-8 days) after injection of the radiotracer. At each time-point, a 45-60 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. A 30-45 minute scanning timeperiod is typical for clinical PET studies.
| Study group | Role | What they receive |
|---|---|---|
| PET Imaging Using 124 IPUH71 | Experimental | Patients will receive an injection of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71, followed by serial PET scanning and blood draws, over a period of 3 days. Optional with a fourth day of PET scanning is to be pursued, in willing patients. Receives: Drug: PET Imaging using 124 IPUH71 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the pharmacokinetics
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.
Measured: 2 years
Secondary outcomes (3)
To study the metabolism
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
Measured: 2 years
To study the biodistribution
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
Measured: 2 years
To study the radiation dosimetry
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samus Therapeutics
- Responsible party
- Sponsor
- Investigators
- Mark Dunphy, DO, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269593
- Sponsor's protocol ID
- 10-139
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2010
- Last updated
- 15 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
- ClinicalTrials.gov ID
- NCT01269593
- Acronym / sponsor ID
- 10-139
- Conditions
- Non-Hodgkin's Lymphoma, Myeloma, Active Solid Malignancy
- Keywords
- PET Scan, 124I-PUH71, 10-139
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Samus Therapeutics
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jan 2011 (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.
The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body \& inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET Imaging Using 124 IPUH71 | Experimental | Drug: PET Imaging using 124 IPUH71Patients will receive an injection of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71, followed by serial PET scanning and blood draws, over a period of 3 days. Optional with a fourth day of PET scanning is to be pursued, in willing patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)
- Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or other tumor response criteria from an MSKCC IRB-approved clinical research protocol.
- This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).
- Age between 18-90
- Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential
Key exclusion criteria (10 listed)
- Previous allergic reaction to contrast medium.
- Hypersensitivity to iodide products.
- Known hyperthyroidism
- Bilirubin > 1.5 x institutional upper limit of normal (ULN)
- AST/ALT >2.5 x ULN
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 |
|---|---|---|
| PET Imaging using 124 IPUH71Also: Blood will be drawn at the multiple time points for pharmacokinetic & metabolite, analyses of 124I-PUH71. We anticipate these time points to be: approximately 10, minutes, 20 minutes, 30 minutes, 1-2 H, and 3-4 H, post-injection. Blood, samples will be obtained in the PET imaging suite.A dose of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71 will be administered intravenously with the patient at rest. 124I-PUH71 scans will be performed at immediately and/or 3-4 hours, 20-24 hours, and 40-80 hours after injection of the radiotracer. Optionally, in willing patients scans will be performed 160-200 hours (~7-8 days) after injection of the radiotracer. At each time-point, a 45-60 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. A 30-45 minute scanning timeperiod is typical for clinical PET studies. | Drug | PET Imaging Using 124 IPUH71 |
Primary outcome
To study the pharmacokinetics
Time frame: 2 years
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.
3 secondary outcomes
To study the metabolism
Time frame: 2 years
To study the biodistribution
Time frame: 2 years
To study the radiation dosimetry
Time frame: 2 years
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 15 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Mark Dunphy, DO principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PET Imaging using 124 IPUH71 in people with Non-Hodgkin's Lymphoma and Myeloma, run by Memorial Sloan Kettering Cancer Center 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 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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 study the pharmacokinetics (time frame: 2 years). 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 15 Jan 2026.