[68Ga]Pentixafor for Neuroendocrine Cancer

Overseen By Kristin Gaimari-Varner, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Yusuf Menda

Must be taking: Somatostatin analog

Disqualifiers: Active infection, Heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how a new imaging agent, Gallium-68 Pentixafor, spreads in patients with neuroendocrine tumors, a cancer type that can occur in various body parts. The researchers aim to determine if imaging results remain consistent over time with repeated scans. The process involves a PET scan, where a small amount of the agent is injected, followed by imaging and a few blood samples. Ideal participants are adults diagnosed with neuroendocrine tumors who have had certain scans and meet specific medical criteria. As an Early Phase 1 trial, this research focuses on understanding how the imaging agent works in people, offering participants the chance to contribute to groundbreaking medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it allows the use of somatostatin analogs during the study.

Is there any evidence suggesting that Gallium-68 Pentixafor is likely to be safe for humans?

Research has shown that Gallium-68 Pentixafor is a promising tool for imaging certain types of cancer, primarily used to detect CXCR4, a protein often found in tumors. Studies indicate that this imaging substance is generally well-tolerated.

Although specific information on side effects is limited, past trials have not raised major safety concerns with Gallium-68 Pentixafor in imaging. It has been used in various types of cancers without significant issues, suggesting potential safety for humans. However, further research is needed to confirm this.

The trial is in its early stages, focusing on understanding how the treatment works in the body. Safety remains a top priority, and the study will closely monitor for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for neuroendocrine cancer, which often involve surgery, chemotherapy, or radiation, [68Ga]Pentixafor offers a novel approach through imaging. This treatment uses Gallium-68 Pentixafor, a radiotracer that targets specific receptors on cancer cells, making it possible to visualize the cancer more accurately with a PET scan. Researchers are excited because this method could lead to better diagnosis and monitoring of the disease, potentially enabling more personalized treatment strategies.

What evidence suggests that Gallium-68 Pentixafor might be an effective treatment for neuroendocrine cancer?

Research has shown that Gallium-68 Pentixafor, which participants in this trial will receive, holds promise for imaging neuroendocrine tumors. It lights up well on scans, making tumors easier to see. In a large study with 690 patients, this imaging agent provided clearer images compared to other methods. While its primary use is for imaging, it may also aid in treatment by targeting specific parts of tumor cells. This remains early research, so although promising, further studies are needed to confirm its effectiveness in treating neuroendocrine cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Yusuf Menda, MD

Principal Investigator

University of Iowa

M. Sue O'Dorisio, MD, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

Adults over 18 with a confirmed neuroendocrine tumor, registered in the Iowa Neuroendocrine Tumor Registry, who've had specific scans within the last 3 months without significant treatment changes. Excludes pregnant women, those planning NET therapy between scans (except for Somatostatin analog), and anyone with illnesses or conditions that could interfere with study participation.

Inclusion Criteria

Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis

Participation in the Iowa Neuroendocrine Tumor Registry

I have a tumor larger than 1.5 cm, confirmed by CT or MRI in the last 3 months.

Exclusion Criteria

Pregnant or lactating women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative pregnancy test will be required for all female subjects with child bearing potential

I am not planning to receive any NET therapy except for Somatostatin analog between two specific scans.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants receive an intravenous administration of [68Ga]Pentixafor followed by PET imaging for about 90 minutes. Blood samples are taken for pharmacokinetic analysis.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, and repeatability of imaging is assessed.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Gallium-68 Pentixafor

Trial Overview [68Ga]Pentixafor's distribution in patients' bodies is being tested to see if it's consistent across multiple scans. This research doesn't apply clinically; images can't be used for medical decisions or shared with oncologists.

How Is the Trial Designed?

Group I: [68Ga]Pentixafor PET scan Experimental Treatment 1 Intervention

4 mCi (range 3-5 mCi) of \[68Ga\]Pentixafor is administered intravenously over 1 minute using an infusion pump. PET imaging is performed from time of infusion for about 90 minutes. Approximately 12 blood samples (\~ 1 tsp) will be taken for pharmacokinetic analysis.

Who Is Running the Clinical Trial?

Yusuf Menda

Lead Sponsor

Trials

3

Recruited

70+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Holden Comprehensive Cancer Center

Collaborator

Trials

27

Recruited

710+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

68 Ga-DOTATATE PET/CT imaging proved effective in identifying previously unknown primary tumors and metastatic disease in sinonasal neuroendocrine tumors, highlighting its potential for better diagnosis compared to conventional imaging methods.

In two cases of esthesioneuroblastoma, 68 Ga-DOTATATE detected abnormal uptake that was not visible on 18F-FDG PET/CT, suggesting it may be crucial for treatment planning, including identifying candidates for targeted therapies like 177 Lu-DOTATATE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. Liu, KY., Goldrich, DY., Ninan, SJ., et al.[2021]

In a study of 52 patients with advanced pancreatic neuroendocrine tumors, (177)Lu-DOTATATE therapy demonstrated significant antitumor activity, achieving an overall disease control rate of 81% with both full and reduced dosages.

Patients receiving the higher dosage of 27.8 GBq had a longer progression-free survival compared to those on the reduced dosage of 18.5 GBq, suggesting that the higher dose is more effective and is recommended for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment with the radiolabelled somatostatin analog Lu-DOTATATE for advanced pancreatic neuroendocrine tumors. Sansovini, M., Severi, S., Ambrosetti, A., et al.[2022]

Gallium-68-dotatate PET/CT imaging demonstrated high sensitivity (94.16%) and specificity (91.89%) in detecting neuroendocrine tumors (NET) and other somatostatin expressing tumors, outperforming traditional CT scans.

In a study of 203 patients, PET/CT identified disease in 19 cases where CT was falsely negative, highlighting its superior ability to detect primary tumor sites and inform patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. Lawal, IO., Ololade, KO., Lengana, T., et al.[2019]

In a study of 22 patients with carcinoid syndrome, treatment with 177Lu-DOTATATE significantly reduced bowel movement frequency from an average of 6.1 to 4.6 per day and flushing episodes from 4.3 to 2.4 per day, indicating effective symptom relief.

The therapy also led to a notable decrease in urinary 5-hydroxyindolacetic acid excretion in 56% of patients, suggesting that 177Lu-DOTATATE can be a valuable option for managing symptoms in patients not adequately controlled by somatostatin analogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE for Symptomatic Control of Refractory Carcinoid Syndrome. Zandee, WT., Brabander, T., Blažević, A., et al.[2021]

Radio-guided surgery (RGS) using (68)Ga-DOTATATE is feasible for identifying gastro-entero-pancreatic neuroendocrine tumors (GEPNETs), with an 81% success rate in detecting gastric and small intestine NETs and 67% for pancreatic NETs.

The study involved 14 patients and demonstrated that RGS can accurately confirm the presence of bowel NETs and metastatic lymph nodes, suggesting it could enhance surgical outcomes, although further research is needed to assess its overall benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Radio-Guided Surgery with ⁶⁸Gallium-DOTATATE in Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors. Sadowski, SM., Millo, C., Neychev, V., et al.[2021]

(68)Ga-DOTATATE PET/CT demonstrated a high sensitivity of 90% and specificity of 82% in detecting recurrent neuroendocrine tumors (NETs) in a study of 63 patients, indicating it is an effective diagnostic tool for monitoring these tumors after curative resection.

The study highlighted that while (68)Ga-DOTATATE PET/CT is accurate, the sensitivity decreased when the scans were reviewed without clinical context, emphasizing the importance of integrating clinical information in the evaluation of NET recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroendocrine tumor recurrence: diagnosis with 68Ga-DOTATATE PET/CT. Haug, AR., Cindea-Drimus, R., Auernhammer, CJ., et al.[2022]

In a study of 43 patients with advanced gastrointestinal neuroendocrine tumors, (177)Lu-Dotatate peptide receptor radionuclide therapy (Lu-PRRT) demonstrated an 84% disease control rate, with a median response duration of 25 months and a median progression-free survival of 36 months.

Both standard and reduced dosages of Lu-PRRT were found to be safe, as none of the patients experienced side effects, even those at higher risk for kidney or bone marrow toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

177 Lu-Dota-octreotate radionuclide therapy of advanced gastrointestinal neuroendocrine tumors: results from a phase II study. Paganelli, G., Sansovini, M., Ambrosetti, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03335670

Gallium 68 Pentixafor in Patients With Neuroendocrine ... This study will evaluate how Gallium-68 Pentixafor is distributed in neuroendocrine tumor patients and if that distribution is consistent through repeated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10792730/

Advances in PET imaging of the CXCR4 Receptor: [68Ga]Ga ... A subsequent retrospective study of [68Ga]Ga-PentixaFor in 690 patients demonstrated highest radiotracer uptake and image contrast in patients ...

3. ajronline.org ajronline.org/doi/10.2214/AJR.25.32708

Head-to-Head Comparison of 68 Ga-PentixaFor PET/CT and ... In a head-to-head comparison of diagnostic performance, 68Ga-PentixaFor PET/CT outperformed FDG PET/CT for hematologic malignancies, whereas FDG PET/CT ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03335670/gallium-68-pentixafor-in-patients-with-neuroendocrine-tumors

Gallium 68 Pentixafor in Patients With Neuroendocrine ... This study will evaluate how Gallium-68 Pentixafor is distributed in neuroendocrine tumor patients and if that distribution is consistent ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0001299823000806

Advances in PET Imaging of the CXCR4 Receptor: [ 68 Ga] ... In the nononcologic setting, [68Ga]Ga-PentixaFor could greatly improve detection for primary aldosteronism and other endocrine abnormalities.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9497673/

Current Status of 68Ga-Pentixafor in Solid Tumours - PMC 68 Ga-Pentixafor is used to non-invasively image the expression of CXCR4 in tumours and has been widely used in haematological malignancies.

7. jnm.snmjournals.org jnm.snmjournals.org/content/56/3/410

Biodistribution and Radiation Dosimetry for the Chemokine ... 68 Ga-pentixafor is a promising PET tracer for imaging the expression of the human chemokine receptor 4 (CXCR4) in vivo.